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amendment list, 28 July 2026

Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

Document SANT-AM-791887 · (COM(2025)1023 – 2025/0404(COD))

Committee on Public Health

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Amendment 132

Tiemo Wölken

Proposal for a regulation

Recital 3 a (new)

Text proposed by the CommissionAmendment
(3a) Devices containing substances referred to in Section 10.4.2 of Annex I, including carcinogenic, mutagenic or toxic for reproduction (CMR) substances and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health, require continued regulatory scrutiny in the light of evolving scientific knowledge. Given the potential risks associated with those substances, such devices should not be eligible for certification without a specified period of validity. Their conformity should therefore be reassessed at least every five years and earlier where new scientific evidence indicates that the safety or performance of the device, or the risks associated with those substances, may be adversely affected.

Or. en

Amendment 133

Tiemo Wölken

Proposal for a regulation

Recital 4 a (new)

Text proposed by the CommissionAmendment
(4a) Software forming part of a medical device may require modifications throughout its lifecycle, including updates intended to improve cybersecurity, interoperability, usability or technical performance. Such modifications should not automatically require a new conformity assessment where they are limited to changes that do not alter the intended purpose, clinical functionality or risk profile of the device and do not introduce new functionalities or changes requiring adaptation of clinical management. By contrast, modifications that extend or alter the intended purpose of the software, introduce new diagnostic or therapeutic functionalities, or result in software intended to diagnose or treat a disease or condition, or to drive or inform clinical management in a manner that changes its classification pursuant to this Regulation, should not be regarded as mere software updates and should remain subject to the applicable conformity assessment procedures. The classification of medical device software, including its updates, should remain proportionate to the significance of its intended purpose and the potential impact of its output on patient care. Where software incorporates or constitutes an AI system within the meaning of Regulation (EU) 2024/1689 and provides information, recommendations or opinions intended to support clinical decision-making, healthcare professionals should retain effective human oversight and independent professional judgement. AI systems that qualify as high-risk AI systems pursuant to Regulation (EU) 2024/1689 should comply with the requirements of that Regulation, including those relating to human oversight. Such simplification should under no circumstances compromise the safety or performance of medical devices or diminish the high level of protection of patient safety and public health ensured by this Regulation.

Or. en

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Amendment 134

Aurelijus Veryga, Tomislav Sokol

Proposal for a regulation

Recital 4 a (new)

Text proposed by the CommissionAmendment
(4a) In order to ensure a high level of public health protection and continuity of patient care, this Regulation should be duly taken into account in the application of other relevant Union legislation. While Union legislative acts pursuing objectives such as environmental protection, chemicals management or sustainability contribute to important public policy objectives, their implementation should take due account of their potential impact on the availability of medical devices, particularly where they may affect materials, substances, components or manufacturing processes. Where the implementation of another Union legislative act is reasonably expected to result in the interruption or discontinuation of the supply of critical medical devices, the Commission should assess the likely impact on patient care and consider appropriate measures to prevent risks to public health and the continuity of patient care.

Or. en

Amendment 135

Laurent Castillo, Margarita de la Pisa Carrión, Ondřej Knotek, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Recital 4 a (new)

Text proposed by the CommissionAmendment
(4a) The rules must be simplified based on the principle of proportionality and a risk-based approach. The administrative requirements must be eased where they do not help to improve patient safety or device performance, whilst maintaining a high level of protection for public health.

Or. fr

Amendment 136

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 5 a (new)

Text proposed by the CommissionAmendment
(5a) Whereas this Regulation should be implemented in full respect of human dignity, fundamental rights and ethical principles recognised by the Member States, in accordance with their constitutional traditions and legal frameworks, as reflected in the Universal Declaration of Human Rights and the Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO on 11 November 1997. The implementation of this Regulation should therefore ensure that innovation in medical devices is aimed exclusively at medical and therapeutic purposes, promoting safe and effective solutions for patients, without facilitating practices that may damage human dignity, integrity of the person or fundamental ethical principles recognised by the Member States.

Or. es

Amendment 137

Laurence Trochu

Proposal for a regulation

Recital 8 a (new)

Text proposed by the CommissionAmendment
(8a) Like nanomaterials, many medical devices may contain and release endocrine disrupters, and even at low doses, these substances are associated with serious risks to human health, particularly to the hormonal system, fertility, neurological development and metabolism; taking account of the innovations that have been achieved in the field of materials, it is worth giving manufacturers more of an incentive to design and manufacture devices in a way that avoids, as far as possible and taking account of the risk-benefit balance, the presence of any endocrine disrupters identified in accordance with Regulation (EC) No 1907/2006 (REACH Regulation) and the requirements of Regulation (EU) 2017/745; this measure would reinforce the level of health protection whilst encouraging innovation in more reliable materials and processes;

Or. fr

Amendment 138

Valentina Palmisano

Proposal for a regulation

Recital 9

Text proposed by the CommissionAmendment
(9) Clinical data are an important source of information for demonstrating the safety and performance of a device. However, the process of generating clinical data is often lengthy and costly. The definition of clinical data should be broadened to enable the use of data generated through studies on the device concerned that are published in scientific literature, but not necessarily peer-reviewed.(9) Clinical data are a fundamental source of information for demonstrating the safety and performance of a device. However, where appropriate, the efficient use of all relevant existing data sources could be facilitated in order to avoid unnecessary duplication of studies and to support timely access to safe and effective devices. The definition of clinical data should be broadened to enable the use of data generated through valid, reliable, and relevant studies on the device concerned that are published in scientific literature, but not necessarily peer-reviewed.

Or. en

Amendment 139

Aurelijus Veryga

Proposal for a regulation

Recital 9

Text proposed by the CommissionAmendment
(9) Clinical data are an important source of information for demonstrating the safety and performance of a device. However, the process of generating clinical data is often lengthy and costly. The definition of clinical data should be broadened to enable the use of data generated through studies on the device concerned that are published in scientific literature, but not necessarily peer-reviewed.(9) Clinical data are an important source of information for demonstrating the safety and performance of a device. However, where appropriate, the efficient use of all relevant existing data sources could be facilitated in order to avoid unnecessary duplication of studies and to support timely access to safe and effective devices. The definition of clinical data should be broadened to enable the use of data generated through valid, reliable, and relevant studies on the device concerned that are published in scientific literature, but not necessarily peer-reviewed.

Or. en

Amendment 140

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Recital 10 a (new)

Text proposed by the CommissionAmendment
(10a) The term ‘well-established technology devices’ must be applied impartially at the technological level. In addition to implantable, surgical and dental devices, there are other categories of medical devices that may also fulfil the criteria laid down in Article 2(72). These could include, as the case may be, substance-based medical devices the safety and performance of which have been proven consistently over time.

Or. fr

Amendment 141

Sirpa Pietikäinen

Proposal for a regulation

Recital 11

Text proposed by the CommissionAmendment
(11) To ensure legal certainty and to safeguard the principle of free movement of goods, the coordination mechanism between national competent authorities for decisions on the regulatory status of a product and on the classification of a device, should be streamlined and, where appropriate, involve external expertise from an expert panel, supported by the European Medicines Agency (EMA). The decision on the regulatory status, however, should remain with the national authorities or, where appropriate, with the Commission acting through implementing acts.(11) To ensure legal certainty and to safeguard the principle of free movement of goods, the coordination mechanism between national competent authorities for decisions on the regulatory status of a product and on the classification of a device, should be streamlined and, where appropriate, involve external expertise from an expert panel, supported by the European Medicines Agency (EMA). The decision on the regulatory status, however, should be with the Commission acting through implementing acts.

Or. en

Justification

To ensure easier and more effective market access for medical devices everywhere in the European Union with one single approval, the approval system of medical devices would need to move towards an EU level approval process rather than on individual national approval processes. Individual processes in every Member State are an obstacle to human health and internal market, as well as a significant unnecessary cost to manufacturers.

Amendment 142

Ruggero Razza, Michele Picaro

Proposal for a regulation

Recital 11 a (new)

Text proposed by the CommissionAmendment
(11a) Where a device has successfully passed the conformity assessment undertaken with the involvement of a notified body and has been CE marked in accordance with Article 20, the coordination activities under Article 4 should not serve as a subsequent supplementary regulatory review, as this may undermine legal certainty and the predictability of the certification process. Accordingly, coordination activities for the products in question should be limited to cases in which there is well-founded evidence that, on the basis of its regulatory status, the product poses an unacceptable risk pursuant to Article 94(a).

Or. it

Amendment 143

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Recital 11 a (new)

Text proposed by the CommissionAmendment
(11a) For a device that has undergone the conformity assessment involving a notified body and that bear the CE marking in accordance with Article 20, the coordination mechanism laid down in Article 4 should not operate as a parallel ex-post regulatory review capable of undermining legal certainty and the predictability of certification. Accordingly, use of the coordination mechanism for such products should be confined to cases where there is substantiated evidence that, on account of its regulatory qualification, the product presents an unacceptable risk within the meaning of Article 94(a).

Or. en

Amendment 144

Ruggero Razza, Michele Picaro

Proposal for a regulation

Recital 11 b (new)

Proposal for regulation

Recital 11 b (new)

Text proposed by the CommissionAmendment
(11b) Where a device has successfully passed the conformity assessment undertaken with the involvement of a notified body and has been CE marked in accordance with Article 18, the coordination activities under Article 3 should not serve as a supplementary regulatory review, as this may undermine legal certainty and the predictability of the certification process. Accordingly, coordination activities for the products in question should be limited to cases in which there is well-founded evidence that, on the basis of its regulatory status, the product poses an unacceptable risk pursuant to Article 89(a).

Or. it

Justification

See the equivalent justification for Article 3(5a).

Amendment 145

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Recital 13 a (new)

Text proposed by the CommissionAmendment
(13a) In order to facilitate access to specialised healthcare while maintaining a high level of protection of health and safety, devices manufactured and used in accordance with Article 5(5) should be allowed to be transferred between health institutions established in the Union, subject to appropriate safeguards. The conditions governing such transfers should ensure that the traceability of the device, the continuity of the applicable quality management system and effective supervision by the competent authorities of the Member States are maintained throughout the transfer and subsequent use of the device. Those conditions should be sufficiently clear to ensure the uniform application of this Regulation, provide legal certainty for health institutions and enable competent authorities to verify compliance through appropriate inspections and enforcement measures.

Or. en

Amendment 146

Tiemo Wölken

Proposal for a regulation

Recital 14

Text proposed by the CommissionAmendment
(14) To ensure a level playing field between devices sold online and those sold via traditional distribution channels, certain information requirements applicable to distance sales should be strengthened. In particular, it should be clarified that Member States may also order, on grounds of public health, the cessation of activity of providers of diagnostic or therapeutic services by way of information society services, as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council12 , without prejudice to national law regulating the medical profession.(14) To ensure a level playing field between devices sold online and those sold via traditional distribution channels, to guarantee a high level of consumer and patient protection across the internal market, and to address the increase of non-compliant devices offered through online marketplaces, certain information requirements applicable to distance sales should be strengthened to complement the obligations of providers of online marketplaces and providers of intermediary services under Regulation (EU) 2022/2065 of the European Parliament and of the Council and with Regulation (EU) 2023/988 of the European Parliament and of the Council. Furthermore, it should be clarified that Member States may also order, on grounds of public health, the cessation of activity of providers of diagnostic or therapeutic services by way of information society services, as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council12 , without prejudice to national law regulating the medical profession.
12 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1, ELI: http://data.europa.eu/eli/dir/2015/1535/oj).12 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1, ELI: http://data.europa.eu/eli/dir/2015/1535/oj).

Or. en

Amendment 147

Valentina Palmisano

Proposal for a regulation

Recital 15

Text proposed by the CommissionAmendment
(15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations.deleted

Or. en

Amendment 148

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 15

Text proposed by the CommissionAmendment
(15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations.deleted

Or. en

Justification

Member States can already consider the most appropriate language for their territory, and should do so considering varied language capacities not only of professionals but also patients.

Amendment 149

Laurence Trochu

Proposal for a regulation

Recital 15

Text proposed by the CommissionAmendment
(15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations.(15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States may consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations, following an assessment at the national level to ensure that all professionals working in the sector relevant to the medical device in question are able to speak a language other than the official language or languages of the Member State. The safety of patients and professionals must remain the top priority, and making savings on translations should not justify any risk in terms of safety or eroding professionals’ working conditions.

Or. fr

Amendment 150

Tiemo Wölken

Proposal for a regulation

Recital 15

Text proposed by the CommissionAmendment
(15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations.(15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States should consider accepting such information also in one or more other official languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users

Or. en

Amendment 151

Valentina Palmisano

Proposal for a regulation

Recital 18

Text proposed by the CommissionAmendment
(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA should be empowered to draw up and publish a list of devices covered by the information obligation. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA, in consultation with key stakeholders and especially patient organisations, should be empowered to draw up a methodology for determining the devices subject to the information obligation. Where appropriate, this could be complemented by an indicative, non-exhaustive list of categories of devices to support consistent application.The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council 41 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.
13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).

Or. en

Amendment 152

Tiemo Wölken

Proposal for a regulation

Recital 18

Text proposed by the CommissionAmendment
(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA should be empowered to draw up and publish a list of devices covered by the information obligation. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.(18) To facilitate and streamline the application of the information obligation in cases of the anticipated interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to those information obligation, a central IT system for the notification, monitoring and information sharing should be made available. That IT system should facilitate the timely submission, sharing and updating of information between manufacturers, competent authorities, the Commission and, where appropriate, EMA. Moreover, the EMA should be empowered to develop and publish a list of devices covered by the information obligations. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, security of supply, and to strengthen health emergency preparedness and response, especially to shortages, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.
13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).

Or. en

Amendment 153

Aurelijus Veryga

Proposal for a regulation

Recital 18

Text proposed by the CommissionAmendment
(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA should be empowered to draw up and publish a list of devices covered by the information obligation. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA, in consultation with key stakeholders and especially patient organisations, should be empowered to draw up a methodology for determining the devices subject to the information obligation. Where appropriate, this could be complemented by an indicative, non-exhaustive list of categories of devices to support consistent application. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.
13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).

Or. en

Amendment 154

Laurence Trochu

Proposal for a regulation

Recital 18

Text proposed by the CommissionAmendment
(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA should be empowered to draw up and publish a list of devices covered by the information obligation. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13. To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.(18) To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA should be empowered to draw up and publish a list of devices covered by the information obligation. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council13. To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG. In order to avoid the exploitation of vulnerabilities, information concerning the availability of critical devices shall not be intended for publication.
13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).13 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).

Or. fr

Amendment 155

Tiemo Wölken

Proposal for a regulation

Recital 20

Text proposed by the CommissionAmendment
(20) To simplify rules and reduce compliance costs, some overly prescriptive requirements, such as the qualification requirements for the person responsible for regulatory compliance or the permanent and continuous availability of that person when not part of the manufacturer’s organisation, should be removed. Also, unnecessary reporting and certification requirements regarding the repackaging or relabelling of devices that are already placed and further distributed within the internal market, for example outside the manufacturer’s official distribution schemes, should be removed.(20) To simplify rules and reduce compliance costs, certain reporting and certification requirements regarding the repackaging or relabelling of devices that are already placed on the market and further distributed within the internal market, for example outside the manufacturer's official distribution schemes, should be removed. Notification to the manufacturer should nevertheless be maintained, as it contributes to the traceability of devices and enables the manufacturer to identify devices affected by defects or subject to field safety corrective actions.

Or. en

Amendment 156

Jessica Polfjärd

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.deleted
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. en

Amendment 157

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement. In order to ensure the consistent application of this Regulation and a high level of protection of health and safety for patients, users and other persons, reprocessing and full refurbishing should comply with the applicable general safety and performance requirements, taking into account the intended purpose, characteristics and properties of the device. Where single-use devices or devices that cannot be further reprocessed undergo full refurbishing within the meaning of this Regulation, the natural or legal person carrying out that process should be considered the manufacturer of the fully refurbished device and should therefore assume all obligations incumbent on manufacturers under this Regulation, including those relating to technical documentation, labelling, traceability, post-market surveillance and vigilance. Fully refurbished devices should be clearly identified as such, and information concerning their refurbished status and traceability should be made available to end users in order to ensure transparency and facilitate their safe use. To promote the uniform application of this Regulation and avoid divergent practices across Member States, manufacturers should determine that a device is intended for single use only on the basis of documented technical, safety and performance considerations. The conditions and requirements applicable to full refurbishing should be further specified, taking into account that certain devices, including certain consumable devices, may not be suitable for such processes.
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. en

Amendment 158

Tiemo Wölken

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and that the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine , in light of the design, construction and the material, chemical, physical and biological properties of the device, whether a device is intended for single use or may be safely reprocessed for reuse. To ensure transparency and facilitate conformity assessment, manufacturers should specify that designation and the grounds for it in the technical documentation. At the same time, the Commission should establish, by means of implementing acts, categories of devices that, by their nature and having regard to hygiene, safety or performance considerations, are intended for single use and are therefore not eligible for reprocessing. Devices falling within those categories should be presumed to be intended for single use only, without requiring manufacturers to provide the grounds for that designation. Accordingly, devices that are not intended for single use and for which the manufacturer can ensure continued compliance with the relevant safety and performance requirements following appropriate reprocessing should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. en

Amendment 159

Aurelijus Veryga

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement. To ensure consistent application of the Regulation, reprocessing and full refurbishing shall ensure compliance with the applicable safety and performance requirements, taking into account the intended purpose, characteristics and properties of the device. Single-use devices and devices which cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person carrying out the full refurbishing shall be considered as the manufacturer of the fully refurbished device and shall fulfil the obligations incumbent on manufacturers under this Regulation, including those relating to labelling, traceability, post-market surveillance and vigilance. The conditions and requirements applicable to full refurbishing shall be defined, taking into account that certain devices, including certain consumable devices, may not be suitable for such processes.
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. en

Amendment 160

Adam Jarubas

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement. To ensure consistent application of the Regulation, reprocessing and full refurbishing shall ensure compliance with the applicable safety and performance requirements, taking into account the intended purpose, characteristics and properties of the device. Single-use devices and devices which cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person carrying out the full refurbishing shall be considered as the manufacturer of the fully refurbished device and shall fulfil the obligations incumbent on manufacturers under this Regulation, including those relating to labelling, traceability, post-market surveillance and vigilance. The conditions and requirements applicable to full refurbishing shall be defined, taking into account that certain devices, including certain consumable devices, may not be suitable for such processes.
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. en

Justification

This approach would not establish an assumption that single-use devices ought to be reprocessed unless manufacturers provide justification for classifying them as intended for single use only. Whether a device is appropriate for reprocessing or complete refurbishment should continue to be assessed by reference to its intended use, technical features, performance characteristics and related risks, without placing an excessive obligation on manufacturers. When complete refurbishment is undertaken, the party performing that activity should take on the relevant responsibilities of a manufacturer, including duties concerning labelling, traceability, post-market surveillance and vigilance.

Amendment 161

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person carrying out the full refurbishment shall be regarded as the manufacturer of the refurbished device from the moment when the product is placed on the market, and must respect the obligations imposed on manufacturers by this Regulation, particularly those relating to labelling, traceability, post-market surveillance and vigilance.
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. fr

Amendment 162

Laurence Trochu

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.(21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices, particularly in light of the risks associated with the inevitable hygiene requirements but also in terms of the standards expected by patients. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, where the hygiene rules so permit and where such re-use is compatible with professional practice and a reasoned approach to cost-effectiveness, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties.
14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final).

Or. fr

Amendment 163

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Recital 21 a (new)

Text proposed by the CommissionAmendment
(21a) Surveillance and certification activities must be kept proportionate throughout a device’s life cycle. In the absence of any serious incident, major safety problem or substantial modification, the repeat assessments must address any changes that have taken place since the last assessment and avoid any unhelpful redundancies.

Or. fr

Amendment 164

Tiemo Wölken

Proposal for a regulation

Recital 22

Text proposed by the CommissionAmendment
(22) The unique device identification (UDI) system and the registration of devices in the European database for medical devices (Eudamed) are fundamental tools for ensuring the traceability and transparency of devices made available on the Union market. To enhance clarity and legal certainty, the respective provisions related to those tools laid down in Regulations (EU) 2017/745 and (EU) 2017/746 should be clarified and streamlined.(22) The unique device identification (UDI) system and the registration of devices in the European database for medical devices (Eudamed) are fundamental tools for ensuring the traceability and transparency of devices made available on the Union market. To enhance clarity, legal certainty and transparency, the respective provisions relating to those tools laid down in Regulations (EU) 2017/745 and (EU) 2017/746 should be clarified and streamlined. It is essential to ensure the swift deployment of a fully functional Eudamed, in particular its publicly accessible modules. Eudamed provides a comprehensive overview of the lifecycle of medical devices made available on the Union market by integrating the electronic systems established under those Regulations. It should enhance transparency by improving access to reliable, up-to-date and meaningful information for patients, healthcare professionals and the public, while also strengthening cooperation and coordination between the competent authorities of the Member States. In order to ensure that Eudamed is accessible and responsive to the needs of its users, patient organisations and healthcare professionals should be appropriately consulted in the development and continuous improvement of its publicly accessible functionalities, including its search functionalities, usability, accessibility and the presentation of information.

Or. en

Amendment 165

Valentina Palmisano

Proposal for a regulation

Recital 22

Text proposed by the CommissionAmendment
(22) The unique device identification (UDI) system and the registration of devices in the European database for medical devices (Eudamed) are fundamental tools for ensuring the traceability and transparency of devices made available on the Union market. To enhance clarity and legal certainty, the respective provisions related to those tools laid down in Regulations (EU) 2017/745 and (EU) 2017/746 should be clarified and streamlined.(22) The unique device identification (UDI) system and the registration of devices in the European database for medical devices (Eudamed) are fundamental tools for ensuring the traceability and transparency of devices made available on the Union market. To enhance clarity and legal certainty, the respective provisions related to those tools laid down in Regulations (EU) 2017/745 and (EU) 2017/746 should be clarified and streamlined. It is essential to prioritise the swift deployment of a fully functional EUDAMED, in particular its publicly accessible modules, which constitute an essential tool for all stakeholders, and especially for patients, to access reliable information on the devices they use. To ensure that EUDAMED is truly patient-centred, patient organisations should be consulted to ensure that information is accessible, understandable, and fit-for-purpose. The database should also make publicly available additional documentation that strengthens transparency and trust in medical devices, such as lay-friendly summaries of notified body assessment reports for high-risk devices, similar to the EMA’s European Public Assessment Report.

Or. en

Amendment 166

Tiemo Wölken

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.deleted
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Amendment 167

Tomislav Sokol

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.deleted
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Amendment 168

Kateřina Konečná

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.(23) Notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Amendment 169

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.(23) Notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Justification

The provisions of the AI act should not be compromised or limited.

Amendment 170

Jessica Polfjärd

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. AI innovation could bring significant benefits for patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements, duplicative conformity procedures and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Justification

Thehorizontal architecture of the AI Act must be better aligned with existingsectoral legislation. This could be achieved by moving Regulations (EU)2017/745 and (EU) 2017/746 from Section A to B in Annex I to Regulation (EU)2024/1689, as proposed by the Commission, and by ensuring relevant safeguards.

Amendment 171

Aurelijus Veryga

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.(23) With appropriate safeguards in place to ensure patient safety, data privacy, and cybersecurity, the use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and hinder patients’ timely access to safe and effective devices. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Amendment 172

Valentina Palmisano

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/168915 of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.(23) With appropriate safeguards in place to ensure patient safety, data privacy, and cybersecurity, the use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/1689 43 of the European Parliament and of the Council could lead to overlaps of requirements and hinder patients’ timely access to safe and effective devices. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should be moved from Section A to Section B. This simplification should be applied in a manner that ensures that such devices continue to comply with relevant requirements of Regulation (EU) 2024/1689, in particular those set out in Chapter III, Section 2. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689.
15 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

Or. en

Amendment 173

Laurence Trochu

Proposal for a regulation

Recital 23 a (new)

Text proposed by the CommissionAmendment
(23a) Devices that are intended for surgically invasive or semi-invasive insertion into the brain or central nervous system, including those that record, stimulate or modify neural activity, could pose a high risk to human health by virtue of their invasive nature, their direct interaction with nervous tissue, and the potentially irreversible consequences for cognitive, sensory or motor function; it is therefore worth ensuring that such devices, even where they are presented as not being intended for medical use and aim to increase human capacities, wellbeing or non-therapeutic uses, for example, are subject to the requirements of the Regulation and regarded as posing the same risks as class III active implantable medical devices, so as to ensure a high level of protection for health and safety whilst preserving innovation capacity.

Or. fr

Amendment 174

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Recital 23 a (new)

Text proposed by the CommissionAmendment
(23a) In order to ensure the uniform and consistent application of Regulation (EU) 2017/745, the criteria for the classification of software under Rule 11 of Annex VIII should be further clarified. The criteria determining whether software qualifies as a medical device should remain distinct from the criteria governing its classification into the applicable risk class. A clear distinction between those concepts is necessary to prevent divergent interpretation and application of the classification rules by manufacturers, notified bodies and competent authorities, and to ensure that software is classified solely on the basis of its intended purpose and the level of risk associated with its functions. Such clarification should avoid the unintended classification of software into higher risk classes where this is not justified by the applicable classification rules, while maintaining a high level of protection of health and safety.

Or. en

Amendment 175

Kristoffer Storm

Proposal for a regulation

Recital 23 a (new)

Text proposed by the CommissionAmendment
(23a) In order to ensure a coherent regulatory framework for in vitro diagnostic medical devices which use artificial intelligence, relevant requirements of the Regulation (EU) 2024/1689 set out in Chapter III, Section 2, of that Regulation should be reflected in the general safety and performance requirements set out in Annex I of the Regulations (EU) 2017/745 and (EU) 2017/746 in a manner that ensures consistency with the requirements of Annex I. That process should avoid duplication and inconsistency of obligations for manufacturers and ensure that the integrity of conformity assessment procedures provided for in Regulation (EU) 2017/746 is maintained.

Or. en

Amendment 176

Laurence Trochu

Proposal for a regulation

Recital 23 b (new)

Text proposed by the CommissionAmendment
(23b) In the context of using brain-computer interfaces (BCIs), the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights recognise some essential human rights; freedom of thought and conscience is therefore protected by Article 9 of the Convention and Article 10 of the Charter; the right to respect for private life is protected by Article 8 of the Convention and Article 7 of the Charter; finally, the principle of non-discrimination is also protected by European law in Article 14 of the Convention and Article 21 of the Charter;

Or. fr

Amendment 177

Laurence Trochu

Proposal for a regulation

Recital 23 c (new)

Text proposed by the CommissionAmendment
(23c) Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence provides for certain prohibitions in order to protect individual autonomy; it is nonetheless necessary to clarify the actual conditions for medical devices that are likely to interfere with users’ intentions, cognitive states or emotions; this is particularly so in the case of brain-computer interfaces;

Or. fr

Amendment 178

Laurence Trochu

Proposal for a regulation

Recital 23 d (new)

Text proposed by the CommissionAmendment
(23d) Invasive and semi-invasive neurotechnologies, particularly brain-computer interfaces, are likely to have a direct impact on people’s mental integrity, especially their mental private life, their ability to make independent decisions, their personal identity and their freedom of thought; given that protecting mental integrity is an essential element of human dignity and of the fundamental rights guaranteed by the Charter of Fundamental Rights of the European Union, it is worth framing the manufacturing of such devices with the specific obligations relating to psychological and neuropsychological risk assessments, voluntary and informed consent, implant reversibility and protection against unauthorised interference, including where such devices are presented as not being intended for medical use; it is particularly worth protecting the most vulnerable people;

Or. fr

Amendment 179

Laurence Trochu

Proposal for a regulation

Recital 23 e (new)

Text proposed by the CommissionAmendment
(23e) Neural data gathered by brain-computer interfaces are highly sensitive data, since they fall under both health data and biometric data within the meaning of Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation - GDPR), given that they reveal a person’s state of health, cognitive processes, emotions and intentions; nevertheless, the GDPR does not recognise such data explicitly as a category sui generis, despite their intrinsically personal nature, which also demonstrates the need to protect cognitive freedom and the right to mental integrity more effectively in relation to neurotechnologies; Moreover, Regulation (EU) 2024/2847 on horizontal cybersecurity requirements for products with digital elements (Cyber Resilience Act) imposes more stringent obligations for design security, vulnerability management and incident reporting for brain-computer interfaces and other online neurotechnologies. However, these general provisions, although relevant, are not specifically designed to prevent the unique risks of manipulating neural functions or the theft of neural data; it is therefore worth supplementing the legislative framework with specific sectoral provisions in the Medical Devices Regulation or dedicated legislation following a detailed impact assessment and before any marketing of such devices;

Or. fr

Amendment 180

Tiemo Wölken

Proposal for a regulation

Recital 24

Text proposed by the CommissionAmendment
(24) The summary of safety and clinical performance under Regulation (EU) 2017/745 and the summary of safety and performance under Regulation (EU) 2017/746 ensure transparency regarding the clinical evidence on which the safety and performance assessment of the device is based. As the drawing up and updating of such a summary is costly, the range of devices subject to that requirement should be clearly limited to those devices for which a systematic assessment of the device’s technical documentation is required pursuant to Regulations (EU) 2017/745 and (EU) 2017/746. Moreover, the summary should be drawn up in a way that is clear for the intended user of the device. To reduce burden and enhance cost-efficiency, additional versions for other persons, such as patients, should not be required. Moreover, as the draft summary is in any case part of the documentation to be submitted to the notified body, a separate validation of the summary by the notified body should not be required. In addition, duplication of information to be provided in the summary and in the instructions for use should be avoided.(24) The summary of safety and clinical performance under Regulation (EU) 2017/745 and the summary of safety and performance under Regulation (EU) 2017/746 ensure transparency regarding the clinical evidence on which the safety and performance assessment of the device is based. As the draft summary is in any case part of the documentation to be submitted to the notified body, a separate validation of the summary by the notified body should not be required. In addition, duplication of information to be provided in the summary and in the instructions for use should be avoided. The summary should be written in lay language to ensure accessibility and readability of the information for all intended users, including patients.

Or. en

Amendment 181

Valentina Palmisano

Proposal for a regulation

Recital 24

Text proposed by the CommissionAmendment
(24) The summary of safety and clinical performance under Regulation (EU) 2017/745 and the summary of safety and performance under Regulation (EU) 2017/746 ensure transparency regarding the clinical evidence on which the safety and performance assessment of the device is based. As the drawing up and updating of such a summary is costly, the range of devices subject to that requirement should be clearly limited to those devices for which a systematic assessment of the device’s technical documentation is required pursuant to Regulations (EU) 2017/745 and (EU) 2017/746. Moreover, the summary should be drawn up in a way that is clear for the intended user of the device. To reduce burden and enhance cost-efficiency, additional versions for other persons, such as patients, should not be required. Moreover, as the draft summary is in any case part of the documentation to be submitted to the notified body, a separate validation of the summary by the notified body should not be required. In addition, duplication of information to be provided in the summary and in the instructions for use should be avoided.(24) The summary of safety and clinical performance under Regulation (EU) 2017/745 and the summary of safety and performance under Regulation (EU) 2017/746 ensure transparency regarding the clinical evidence on which the safety and performance assessment of the device is based. As the draft summary is in any case part of the documentation to be submitted to the notified body, a separate validation of the summary by the notified body should not be required. In addition, duplication of information to be provided in the summary and in the instructions for use should be avoided. The summary should be written in lay language to ensure accessibility and readability for patients and other intended users. For class III and implantable devices, or where justified by the device's risk profile, the availability of a summary for patients should be maintained to support informed decision-making and transparency

Or. en

Amendment 182

Laurence Trochu

Proposal for a regulation

Recital 25

Text proposed by the CommissionAmendment
(25) In accordance with Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies exercise a key function in the medical device regulatory system as the issuance of a certificate by a notified body is a prerequisite for market access of most devices. In order to ensure that devices benefit from uniform and predictable conditions for market access, the accountability of notified bodies and the degree of harmonisation of their conformity assessment activities should therefore be enhanced. For that purpose, the process for the assessment of applicant notified bodies and their designation should be streamlined. Moreover, the oversight of notified bodies should be tightened through the involvement of joint assessment teams also in the monitoring of notified bodies. In light of such changes, the full reassessment of notified bodies every five years is no longer required and should therefore be removed.(25) In accordance with Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies exercise a key function in the medical device regulatory system as the issuance of a certificate by a notified body is a prerequisite for market access of most devices. In order to ensure that devices benefit from uniform and predictable conditions for market access, the accountability of notified bodies and the degree of harmonisation of their conformity assessment activities should therefore be enhanced. For that purpose, the process for the assessment of applicant notified bodies and their designation should be streamlined. Moreover, the oversight of notified bodies should be tightened through the involvement of joint assessment teams also in the monitoring of notified bodies. In light of such changes, the full reassessment of notified bodies every five years is no longer required and should therefore be removed. Nevertheless, technologies have developed considerably since the aims of the notified bodies were defined, so it is worth integrating into them an evaluation of the potential ethical dimension presented by the medical device or in vitro diagnostic device. In fact, the conformity assessments by the notified bodies concern medical devices that may have major repercussions for the health, independence and dignity of patients, particularly brain-computer interfaces, neurotechnologies and devices using sensitive data once they are given a specific legislative framework, but also devices that facilitate pre-implantation diagnostics in the case of in vitro fertilisation; it is therefore essential to integrate an ethical dimension into this assessment, as well as the proportionality of the risks and benefits; the notified bodies should therefore verify, as part of their assessment, that the manufacturer has taken proper account of these ethical aspects in the risk assessment, clinical evaluation and technical file, by relying on the opinions of independent biomedical-ethics experts as appropriate and verifying that brief but explicit documentation to give to patients has been planned;

Or. fr

Amendment 183

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 25

Text proposed by the CommissionAmendment
(25) In accordance with Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies exercise a key function in the medical device regulatory system as the issuance of a certificate by a notified body is a prerequisite for market access of most devices. In order to ensure that devices benefit from uniform and predictable conditions for market access, the accountability of notified bodies and the degree of harmonisation of their conformity assessment activities should therefore be enhanced. For that purpose, the process for the assessment of applicant notified bodies and their designation should be streamlined. Moreover, the oversight of notified bodies should be tightened through the involvement of joint assessment teams also in the monitoring of notified bodies. In light of such changes, the full reassessment of notified bodies every five years is no longer required and should therefore be removed.(25) In accordance with Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies exercise a key function in the medical device regulatory system as the issuance of a certificate by a notified body is a prerequisite for market access of most devices. In order to ensure that devices benefit from uniform and predictable conditions for market access, the accountability of notified bodies and the degree of harmonisation of their conformity assessment activities should therefore be enhanced. For that purpose, the process for the assessment of applicant notified bodies and their designation should be streamlined. Moreover, the oversight of notified bodies should be tightened through the involvement of joint assessment teams also in the monitoring of notified bodies. In light of such changes, the full reassessment of notified bodies every five years is no longer required and should therefore be removed. The governance structure of notified bodies should be strengthened to ensure a level of harmonisation, consistency and interoperability.

Or. en

Justification

While existing provisions address designation and oversight of notified bodies, the harmonisation of conformity assessment practices across the Union remains insufficient. Divergent interpretations and inconsistent audit practices between notified bodies create an uneven playing field for manufacturers and undermine regulatory predictability. Strengthening the governance structure to ensure interoperability and consistency is essential to achieve a truly integrated and competitive European medical device market.

Amendment 184

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 25 a (new)

Text proposed by the CommissionAmendment
(25a) Within the Union, notified bodies should equally recognise and rely upon assessments and evidence that have already been evaluated, whether by the same or another designated notified body. Unnecessary repetition of assessments - including quality management system audits, technical documentation reviews, biocompatibility assessments, packaging validations and sterilisation validations - should be avoided where existing evidence remains relevant and scientifically valid.

Or. en

Justification

Manufacturers are frequently required to repeat assessments and submit evidence that has already been evaluated under equivalent regulatory requirements. This leads to unnecessary administrative burden, increased certification timelines and inefficient use of notified body resources without improving patient safety.Wherever equivalent evidence has already been assessed under the MDR or under internationally recognised regulatory frameworks, notified bodies should rely on these existing assessments unless there is an objective, documented justification for requesting additional evidence.

Amendment 185

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 25 b (new)

Text proposed by the CommissionAmendment
(25b) To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations. Notified bodies shall also take into account the results of audits carried out under international programs recognised by the Union, such as ISO 13485 certification and the Medical Device Single Audit Program (MDSAP), when conducting conformity assessments and quality management system audits under this Regulation, insofar as those certifications cover the applicable requirements of this Regulation.

Or. en

Justification

Recognising ISO 13485 and MDSAP certifications as relevant evidence allows notified bodies to use existing assessment results, reducing redundant audits and administrative burden — while all MDR safety and performance requirements continue to be fully met.

Amendment 186

Ondřej Dostál

Proposal for a regulation

Recital 26 a (new)

Text proposed by the CommissionAmendment
(26a) Limitations in the funding model of notified bodies may create incentives to prolong or intensify conformity assessment activities for reasons unrelated to quality or patient safety, resulting in unjustified differences in certification practices between Member States and disproportionate burdens for manufacturers, particularly those with smaller product portfolios.

Or. en

Amendment 187

Ondřej Dostál

Proposal for a regulation

Recital 26 b (new)

Text proposed by the CommissionAmendment
(26b) Significant differences in the frequency, scope and repetition of conformity assessments carried out by notified bodies across Member States reduce the predictability of the regulatory framework and create incentives for both Union and third-country manufacturers to engage in forum shopping when seeking access to the Union market.

Or. en

Amendment 188

Tiemo Wölken

Proposal for a regulation

Recital 27

Text proposed by the CommissionAmendment
(27) Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC16 and with regard to orphan devices, notified bodies should therefore be required to reduce their fees for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746.(27) Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC16 and with regard to orphan devices, notified bodies may therefore be required to reduce their annual fees for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746. However, notified bodies that are micro enterprises should not be obliged to apply such fee reduction.
16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

Or. en

Amendment 189

Laurence Trochu

Proposal for a regulation

Recital 27

Text proposed by the CommissionAmendment
(27) Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC16 and with regard to orphan devices, notified bodies should therefore be required to reduce their fees for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746.(27) Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC16 and with regard to orphan devices, the fees payable to notified bodies may be adjusted for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746, but without compromising the profitability of the notified bodies.
16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

Or. fr

Justification

If certain kinds of undertaking or device are less profitable than others as the result of a mandatorily differentiated tariff schedule, it could force the notified bodies to reject or delay certification applications, thereby reducing patients’ access to those devices.

Amendment 190

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 27

Text proposed by the CommissionAmendment
(27) Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC16 and with regard to orphan devices, notified bodies should therefore be required to reduce their fees for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746.(27) Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC16 and with regard to orphan devices and paediatric devices, notified bodies should therefore be required to reduce their fees for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746.
16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).16 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

Or. en

Amendment 191

Laurence Trochu

Proposal for a regulation

Recital 28

Text proposed by the CommissionAmendment
(28) To enhance predictability regarding the fees charged by notified bodies for conformity assessment activities of devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 and to prevent excessively high fees, the Commission should be empowered to adopt implementing acts to set the level and structure of fees by the notified bodies, without prejudice to the potential application of Articles 101 and/or 102 of the Treaty on the Functioning of the European Union to the way notified bodies set their prices or carry out their economic activities.(28) Given the responsibilities that notified bodies have in the certification process, they are a critical stage in the value chain for medical devices and it is crucial to maintain their presence in large numbers within the Union. It is therefore worth giving them the freedom to set their fees, while inviting them to provide evidence of their transparency and predictability, for conformity assessment activities of devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 without prejudice to the potential application of Articles 101 and/or 102 of the Treaty on the Functioning of the European Union.

Or. fr

Amendment 192

Tiemo Wölken

Proposal for a regulation

Recital 29 a (new)

Text proposed by the CommissionAmendment
(29a) Patients and their representative organisations possess valuable knowledge and experience regarding the use of medical devices, the management of diseases and the outcomes that matter most to patients. Their expertise should therefore be appropriately integrated into the implementation and continuous development of the Union regulatory framework for medical devices. Structured and meaningful involvement of patients should contribute to greater transparency, improve the quality and relevance of regulatory decision-making and strengthen public confidence in the regulatory system. To facilitate the systematic exchange of information and experience, the Medical Device Coordination Group (MDCG) should establish appropriate arrangements for the regular involvement of patient representatives in its work. Such participation should be organised in a transparent and balanced manner, ensuring that patient representatives are able to contribute effectively alongside other stakeholders. Where patient representatives participate in activities carried out under this Regulation, appropriate arrangements should be made to reimburse the costs incurred and, where justified, to provide appropriate remuneration in accordance with applicable Union rules.

Or. en

Amendment 193

Laurence Trochu

Proposal for a regulation

Recital 30

Text proposed by the CommissionAmendment
(30) For lower and medium-risk devices, the involvement of notified bodies in the conformity assessment process should be reduced so that it is proportionate to the risk class of the device. For example, for class IIa and non-implantable class IIb devices, or most class C devices, where the notified body is to assess the technical documentation on a sampling basis, it should be clarified that the technical documentation assessment is only needed for one representative device of a category of devices or a generic device group, or in the case of class B devices only for one device from the manufacturer’s product portfolio. Additional technical documentation assessment during surveillance activities should only be carried out when potential concerns exist based on data available from the post-market surveillance system. As class A sterile devices are of low risk, notified body involvement for those devices should be removed.(30) For lower and medium-risk devices, the involvement of notified bodies in the conformity assessment process should be reduced so that it is proportionate to the risk class of the device. For example, for class IIa and non-implantable class IIb devices, or most class C devices, where the notified body is to assess the technical documentation on a sampling basis, it should be clarified that the technical documentation assessment is only needed for one representative device of a category of devices or a generic device group, or in the case of class B devices only for one device from the manufacturer’s product portfolio, where the latter provides documentary evidence that the device for which the documentation has been assessed is a representative device. Additional technical documentation assessment during surveillance activities should only be carried out when potential concerns exist based on data available from the post-market surveillance system. As class A sterile devices are of low risk, notified body involvement for those devices should be removed.

Or. fr

Amendment 194

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 31

Text proposed by the CommissionAmendment
(31) To support innovation and the development and availability of breakthrough technology and of devices intended for small groups of patients, the conformity assessment procedures should be adapted to address the specific situation of those devices. For that purpose, criteria for breakthrough devices and orphan devices should be included in Regulations (EU) 2017/745 and (EU) 2017/746, based on guidance developed by the Medical Device Coordination Group. If the status as a breakthrough device or orphan device is confirmed by an expert panel, the review of the device by the notified body should be prioritised, if necessary with additional advice from the expert panels.(31) To support innovation and the development and availability of breakthrough technology and of devices intended for small groups of patients, the conformity assessment procedures should be adapted to address the specific situation of those devices. For that purpose, criteria for breakthrough devices, orphan devices, and paediatric devices should be included in Regulations (EU) 2017/745 and (EU) 2017/746, based on guidance developed by the Medical Device Coordination Group. If the status as a breakthrough device or orphan device is confirmed by an expert panel, the review of the device by the notified body should be prioritised, if necessary with additional advice from the expert panels.

Or. en

Amendment 195

Tiemo Wölken

Proposal for a regulation

Recital 31 a (new)

Text proposed by the CommissionAmendment
(31a) Regulation (EU) 2021/2282 provides for joint clinical assessments of medical devices classified as class IIb or III and of in-vitro diagnostic medical devices classified as class D. In order to ensure coherence between the Union regulatory framework governing the placing on the market of medical devices and the framework for health technology assessment, it is appropriate to strengthen cooperation between the MDCG established under this Regulation and the Coordination Group established pursuant to Regulation (EU) 2021/2282. The exchange of scientific and technical expertise and information on matters of common interest should contribute to greater regulatory coherence, avoid unnecessary duplication of work and facilitate timely patient access to safe, effective and innovative medical devices, while fully respecting the distinct objectives, responsibilities and independence of each body.

Or. en

Amendment 196

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Recital 31 a (new)

Text proposed by the CommissionAmendment
(31a) In order to ensure that the specific needs of children are adequately addressed, paediatric medical devices should be recognised as a distinct category under this Regulation. Not all medical devices intended for paediatric use fall within the categories of breakthrough, orphan or niche devices, although they may face similar challenges in their development, clinical evaluation and market availability due to the limited size of the target population and the specific characteristics of paediatric patients. The inclusion of a definition of paediatric devices and the consideration of their specificities throughout the relevant provisions of this Regulation are therefore necessary to promote the development and availability of safe and effective devices intended for children, while ensuring a high level of protection of health and safety and the consistent application of this Regulation.

Or. en

Amendment 197

Tiemo Wölken

Proposal for a regulation

Recital 34

Text proposed by the CommissionAmendment
(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed, unless the notified body considers it necessary to limit the validity on justified grounds, such as in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices.(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed, unless the notified body considers it necessary to limit the validity on justified grounds, such as in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices. Where breakthrough devices and orphan devices are concerned, the initial validity of the certificate should remain limited to a maximum period of five years. As those devices may be certified subject to conditions requiring the generation of additional clinical evidence through post-market clinical follow-up, the notified body should reassess compliance with those conditions before renewing the certificate in order to ensure that the benefit-risk ratio remains favourable and to safeguard a high level of patient safety.

Or. en

Amendment 198

Laurence Trochu

Proposal for a regulation

Recital 34

Text proposed by the CommissionAmendment
(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed, unless the notified body considers it necessary to limit the validity on justified grounds, such as in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices.(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed for the devices that pose the lowest risks, unless the notified body considers it necessary to limit the validity on justified grounds, such as in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices. The maximum validity period before recertification should be 10 years for the most sensitive implantable medical devices.

Or. fr

Amendment 199

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 34

Text proposed by the CommissionAmendment
(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed, unless the notified body considers it necessary to limit the validity on justified grounds, such as in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices.(34) When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed, unless the notified body considers it necessary to limit the validity on justified grounds, such as an opinion expressed by an Expert Panel, or in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices or certain high-risk devices.

Or. en

Justification

With the possibility of open-ended validity of certificates, it should be made clear that this may nevertheless not be an appropriate solution for all devices, such as high-risk devices, or simply where Expert Panel opinion has indicated reservations about the appropriateness of an open-ended certificate for a certain device.

Amendment 200

Laurence Trochu

Proposal for a regulation

Recital 35

Text proposed by the CommissionAmendment
(35) In order to respond to a public health emergency at Union level recognised in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council17, or to ensure the supply of medical devices and in vitro diagnostic medical devices falling under the definition of medical countermeasures within the framework of Council Regulation (EU) 2022/237218, the Commission should be able to authorise, by means of implementing acts, the placing on the market or putting into service of devices for which a conformity assessment in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 has not been carried out. Moreover, where specific CE marked devices are needed, for example in greater numbers or with an adapted intended purpose, to respond to a public health emergency or a disaster or crisis, Member States, or the Commission, should be able to exempt manufacturers from certain requirements related to the manufacturing, design or intended purpose of the device.(35) In order to respond to a public health emergency at Union level recognised in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council17, or to ensure the supply of medical devices and in vitro diagnostic medical devices falling under the definition of medical countermeasures within the framework of Council Regulation (EU) 2022/237218, Member States should be able to authorise, for their domestic market alone, the placing on the market or putting into service of devices for which a conformity assessment in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 has not been carried out, for a period limited to the public health emergency in question and under the strict supervision of the national authorities. Medical devices and in vitro diagnostic medical devices authorised within this framework and which are not CE marked may not be used legitimately to justify any assaults on fundamental freedoms or the risks to mental health. Moreover, where specific CE marked devices are needed, for example in greater numbers or with an adapted intended purpose, to respond to a public health emergency or a disaster or crisis, Member States should be able to exempt manufacturers from certain requirements related to the manufacturing, design or intended purpose of the device insofar as they reproduce precisely devices that have already been CE marked, without prejudice to any intellectual property rights. The traceability obligations should not be eased.
17 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj).17 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj).
18 Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 6.12.2024, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).18 Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 6.12.2024, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).

Or. fr

Amendment 201

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 35 a (new)

Text proposed by the CommissionAmendment
(35a) Strengthening the Union medical devices sector should help to reduce reliance on third countries in strategic areas, boost supply chains for medical devices, critical ingredients and essential raw materials, and improve the sustainability, resilience and long-term capacity of Union health systems;

Or. es

Amendment 202

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 35 b (new)

Text proposed by the CommissionAmendment
(35b) A robust and innovative medical devices sector is an essential part of the Union’s biotechnology ecosystem, supporting the application of advances in science and biotechnology relating to safe, effective and innovative healthcare solutions for patients.

Or. es

Amendment 203

Tiemo Wölken

Proposal for a regulation

Recital 36

Text proposed by the CommissionAmendment
(36) To ensure that the legal framework governing the highly innovative sectors of medical devices and in vitro medical devices is future-proof and able to support innovation, Member States and the Commission should be able to establish regulatory sandboxes in the field of medical devices or in vitro diagnostic medical devices to facilitate the development and testing of innovative devices or regulatory approaches under strict oversight.(36) Member States and the Commission should be able to establish regulatory sandboxes in the field of medical devices or in vitro diagnostic medical devices. Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to identify the most appropriate means of regulating innovation based on real-world evidence. Regulatory sandboxes should provide a structured and safe context for experimentation and enable, where appropriate, in a real-world environment, the testing of innovative devices, technologies, services or regulatory approaches for a limited period and within a limited part of a sector or area under regulatory supervision, while ensuring that appropriate safeguards are in place.

Or. en

Amendment 204

Laurence Trochu

Proposal for a regulation

Recital 36

Text proposed by the CommissionAmendment
(36) To ensure that the legal framework governing the highly innovative sectors of medical devices and in vitro medical devices is future-proof and able to support innovation, Member States and the Commission should be able to establish regulatory sandboxes in the field of medical devices or in vitro diagnostic medical devices to facilitate the development and testing of innovative devices or regulatory approaches under strict oversight.(36) To ensure that the legal framework governing the highly innovative sectors of medical devices and in vitro medical devices is future-proof and able to support innovation, Member States and the Commission should be able to establish regulatory sandboxes in the field of medical devices or in vitro diagnostic medical devices to facilitate the development and testing of innovative devices or regulatory approaches under strict oversight; in the specific case of neurotechnology devices, this sandbox should have mental integrity at the heart of the assessment process;

Or. fr

Amendment 205

Tiemo Wölken

Proposal for a regulation

Recital 36 a (new)

Text proposed by the CommissionAmendment
(36a) The Commission should be empowered to establish Union regulatory sandboxes where there is evidence that the existing regulatory framework may impede or significantly delay the development, conformity assessment or access to the Union market of innovative devices, emerging technologies or innovative regulatory approaches, in particular where their novel scientific or technological characteristics are not adequately accommodated by the existing regulatory framework. Union regulatory sandboxes should provide a structured environment for the development, validation and testing of innovative devices and regulatory approaches under the supervision of the Commission and the competent authorities, while ensuring a high level of protection of public health and that the applicable requirements of this Regulation relating to the safety and performance of devices continue to apply. The experience gained through Union regulatory sandboxes should support evidence-based improvements to the regulatory framework and, where appropriate, the development of guidance or legislative amendments.

Or. en

Amendment 206

Tiemo Wölken

Proposal for a regulation

Recital 36 b (new)

Text proposed by the CommissionAmendment
(36b) Manufacturers, prospective manufacturers and any other entities taking part in a regulatory sandbox should not have their responsibilities or liability under applicable Union and national law affected by their participation. Those entities should remain liable for any harm caused to third parties as a result of activities carried out within the regulatory sandbox. The establishment or supervision of a regulatory sandbox by a competent authority, the Commission or any other Union body should not give rise to any assumption of liability by those authorities or bodies.

Or. en

Amendment 207

Laurence Trochu

Proposal for a regulation

Recital 37

Text proposed by the CommissionAmendment
(37) Article 4 of Directive 2010/63/EU of the European Parliament and the Council19 prescribes that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of an animal-based procedure. Non-animal tests such as New Approach Methodologies (NAMs), which include innovative in-vitro (cell or tissue-based), in-chemico (chemical-based), in-silico (computer-based) approaches, or combinations of these, can increasingly replace or complement animal-based tests for safety and performance studies. The use of non-animal methods, including NAMs, to provide scientific evidence in clinical and non-clinical studies should therefore be promoted.(37) Article 4 of Directive 2010/63/EU of the European Parliament and the Council19 prescribes that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of an animal-based procedure. Non-animal tests such as New Approach Methodologies (NAMs), which include innovative in-vitro (cell or tissue-based), in-chemico (chemical-based), in-silico (computer-based) approaches, or combinations of these, can increasingly replace or complement animal-based tests for safety and performance studies. The use of non-animal methods, including NAMs, to provide scientific evidence in clinical and non-clinical studies should therefore be promoted. These new approaches should also take account of differences between men and women, particularly anatomical, physiological and hormonal differences where relevant.
19 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276 20.10.2010, p. 33, ELI: http://data.europa.eu/eli/dir/2010/63/2019-06-26 ).19 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276 20.10.2010, p. 33, ELI: http://data.europa.eu/eli/dir/2010/63/2019-06-26 ).

Or. fr

Amendment 208

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 39

Text proposed by the CommissionAmendment
(39) Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted.deleted

Or. en

Amendment 209

Tiemo Wölken

Proposal for a regulation

Recital 39

Text proposed by the CommissionAmendment
(39) Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted.deleted

Or. en

Amendment 210

Laurence Trochu

Proposal for a regulation

Recital 39

Text proposed by the CommissionAmendment
(39) Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted.(39) Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted, without compromising the competitiveness of the most innovative manufacturers, who are making the effort to be the first to produce clinical data. Assessment data obtained under Regulation (EU) 2021/2282 on health technology assessment may itself be used by manufacturers for their own (CE) marking file.

Or. fr

Amendment 211

Stine Bosse, Andreas Glück, Billy Kelleher

Proposal for a regulation

Recital 43

Text proposed by the CommissionAmendment
(43) There is a growing number of clinical studies involving, simultaneously, a clinical trial of a medicinal product subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council20 , a performance study of an in vitro diagnostic medical device subject to Regulation (EU) 2017/746 or a clinical investigation of a medical device subject to Regulation (EU) 2017/745 (‘combined studies’). To address concerns raised regarding the complexity of applying multiple Regulations to those combined studies, sponsors should be enabled to submit a single application for a combined study leading to its coordinated assessment under Regulation (EU) No 536/2014. Regulations (EU) 2017/746 and Regulation (EU) 2017/745 should not be applicable where a single application has been submitted.(43) There is a growing number of clinical studies involving, simultaneously, a clinical trial of a medicinal product subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council20 , a performance study of an in vitro diagnostic medical device subject to Regulation (EU) 2017/746 or a clinical investigation of a medical device subject to Regulation (EU) 2017/745 (‘combined studies’). To address concerns raised regarding the complexity of applying multiple Regulations to those combined studies, sponsors should be enabled to submit a single application for a combined study leading to its coordinated assessment under Regulation (EU) No 536/2014. Regulations (EU) 2017/746 and Regulation (EU) 2017/745 should not be applicable where a single application has been submitted. The use of a single application for combined studies should facilitate the conduct of clinical trials falling under Regulation (EU) 2017/536 and Regulation (EU) 2017/746 by reducing procedural complexity for studies involving diagnostic tests. To ensure its effective application, overlaps with the EUDAMED system for submissions relating to clinical investigations and performance studies should be avoided. Experience gained from the COMBINE programme should be taken into account in the implementation of this Regulation.
20 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.1, ELI; http://data.europa.eu/eli/reg/2014/536/oj).20 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.1, ELI; http://data.europa.eu/eli/reg/2014/536/oj).

Or. en

Justification

This strengthened recital supports the recognition of the COMBINE programme and the objective of avoiding overlaps between the Clinical Trials Information System (CTIS) and EUDAMED. It also supports the establishment of a coherent and predictable framework for integrated drug-device combinations (iDDCs) as proposed by MEP Andreas Glueck. While streamlining clinical study procedures is important, similar principles should also apply throughout the regulatory lifecycle.

Amendment 212

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Recital 43 a (new)

Text proposed by the CommissionAmendment
(43a) In order to ensure a high level of protection of public health and the consistent application of this Regulation, clinical investigation data relied upon by manufacturers for the purpose of demonstrating conformity should meet equivalent standards of protection of subjects, scientific validity and data integrity, irrespective of whether those data were generated within or outside the scope of this Chapter. The deletion of specific Union rules governing certain non-commercial clinical investigations should not result in clinical evidence being used for conformity assessment where the quality, reliability and integrity of the underlying data cannot be adequately verified. Competent authorities and, where applicable, notified bodies should therefore be able to verify that such data were generated under requirements providing an equivalent level of protection and reliability before they are accepted as clinical evidence for conformity assessment.

Or. en

Amendment 213

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 45

Text proposed by the CommissionAmendment
(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. In addition, patient representatives should be systematically included in expert panels to ensure that patients’ perspectives are taken into account. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.

Or. en

Amendment 214

Valentina Palmisano

Proposal for a regulation

Recital 45

Text proposed by the CommissionAmendment
(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. In addition, patient representatives should be systematically included in expert panels to ensure that patients’ perspectives are taken into account. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.

Or. en

Amendment 215

Aurelijus Veryga

Proposal for a regulation

Recital 45

Text proposed by the CommissionAmendment
(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. In addition, patient representatives should be systematically included in expert panels to ensure that patients’ perspectives are taken into account. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.

Or. en

Amendment 216

Laurence Trochu

Proposal for a regulation

Recital 45

Text proposed by the CommissionAmendment
(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.(45) The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. It is worth ensuring that the new experts who are brought in have no conflict of interests. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.

Or. fr

Amendment 217

Laurence Trochu

Proposal for a regulation

Recital 47

Text proposed by the CommissionAmendment
(47) The Union participates in the International Medical Device Regulators Forum (IMDRF)22, which is a voluntary group of regulators from around the world that aims to accelerate international regulatory harmonisation and convergence in the field of medical devices and in vitro diagnostic medical devices. To a large extent, the Union regulatory system for medical devices reflects guidelines developed in the framework of the IMDRF. To increase efficiency, reduce duplication of regulatory efforts and promote global convergence, the Commission and Member States should actively participate in, and make use of, international regulatory cooperation and reliance mechanisms or reliance programmes.(47) The Union participates in the International Medical Device Regulators Forum (IMDRF)22, which is a voluntary group of regulators from around the world that aims to accelerate international regulatory harmonisation and convergence in the field of medical devices and in vitro diagnostic medical devices. To a large extent, the Union regulatory system for medical devices reflects guidelines developed in the framework of the IMDRF. To increase efficiency, reduce duplication of regulatory efforts and promote global convergence, the Commission, the Council and Member States should actively participate in, and make use of, international regulatory cooperation and reliance mechanisms or reliance programmes, whilst applying the principle of cooperation in good faith among the institutions referred to in Article 13(2) TUE.
22 International Medical Device Regulators Forum (IMDRF) | International Medical Device Regulators Forum22 International Medical Device Regulators Forum (IMDRF) | International Medical Device Regulators Forum

Or. fr

Amendment 218

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 47 a (new)

Text proposed by the CommissionAmendment
(47a) Recognition of Existing Evidence and Assessments: The Union's medical device regulatory framework should evolve towards greater convergence and international reliance with leading global regulatory systems, in particular the United States Food and Drug Administration (FDA) system, with a view to establishing a more predictable, efficient and internationally interoperable conformity assessment ecosystem. To this end, the Commission and the Medical Device Coordination Group should work towards enhanced mutual recognition of audit and review results, especially regarding clinical evidence with trusted regulatory partners, including through the Medical Device Single Audit Program (MDSAP).

Or. en

Justification

Manufacturers are frequently required to repeat assessments and submit evidence that has already been evaluated under equivalent regulatory requirements. This leads to unnecessary administrative burden, increased certification timelines and inefficient use of notified body resources without improving patient safety. Wherever equivalent evidence has already been assessed under the MDR or under internationally recognised regulatory frameworks, notified bodies should rely on these existing assessments unless there is an objective, documented justification for requesting additional evidence.

Amendment 219

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 51 a (new)

Text proposed by the CommissionAmendment
(51a) Activities of financiers in connection with the financing of assets that serve to amortize financing costs, are not considered a supply of asset for distribution, consumption or use on the Union market.

Or. en

Justification

It is important to clarify in the legal text that while leasing companies technically own a given medical device, the leasing company is not in actuality a "distributor" of the medical device, but a third party delivering a financial service. The leasing company itself does not perform nor deliver any medical services.

Amendment 220

Valentina Palmisano

Proposal for a regulation

Recital 58

Text proposed by the CommissionAmendment
(58) In order to allow all affected parties sufficient time to take the necessary measures to comply with this Regulation, the application of certain provisions should be deferred. However, provisions that do not require time for preparation should be applicable from the date of the entry into force of this Regulation.(58) In order to allow all affected parties sufficient time to take the necessary measures to comply with this Regulation, the application of certain provisions should be deferred. In particular, the application of simplification measures reducing regulatory oversight, including those affecting post-market surveillance, conformity assessment, and certification requirements, should be conditional upon the full completion and functionality of EUDAMED, including a fully operational signal detection system. However, provisions that do not require time for preparation or that do not reduce the level of regulatory oversight should be applicable from the date of the entry into force of this Regulation.

Or. en

Amendment 221

Valentina Palmisano

Proposal for a regulation

Recital 59 a (new)

Text proposed by the CommissionAmendment
(59a) Patients and patient organisations should be systematically involved in the governance, implementation and evaluation of this Regulation to ensure that regulatory decisions reflect patient needs, preferences and real-world outcomes. Based on the model of the European Medicines Agency’s Patient and Consumer Working Party, a dedicated subgroup within the MDCG to facilitate information exchange and ensure meaningful involvement of patient representatives in the implementation of the Regulation should be established, including adequate compensation.

Or. en

Amendment 222

András Tivadar Kulja

Proposal for a regulation

Recital 59 a (new)

Text proposed by the CommissionAmendment
(59a) Whereas robust safeguards for product and patient safety remain at the core of Regulation (EU) 2017/745, any simplification of regulatory procedures should maintain a high level of patient protection, preserve trust in the safety and performance of medical devices, and ensure that streamlined procedures do not weaken clinical evidence requirements.

Or. en

Amendment 223

András Tivadar Kulja

Proposal for a regulation

Recital 59 b (new)

Text proposed by the CommissionAmendment
(59b) In order to ensure a coherent regulatory framework for medical devices incorporating artificial intelligence, the classification rules laid down in this Regulation should appropriately reflect the risks associated with such technologies. To avoid duplication of requirements, medical devices and in vitro diagnostic medical devices that are high-risk AI systems, or that incorporate high-risk AI systems as safety components, should be regulated under this Regulation, ensuring a single and coherent conformity assessment procedure.

Or. en

Amendment 224

András Tivadar Kulja

Proposal for a regulation

Recital 59 c (new)

Text proposed by the CommissionAmendment
(59c) To safeguard a high level of protection of health and safety, medical devices incorporating a high-risk AI system within the meaning of Regulation (EU) 2024/1689, or constituting such a system, should enable effective human oversight, where appropriate. Human oversight measures should be proportionate to the intended purpose, level of autonomy and risks associated with the device, form part of the manufacturer's risk management process, and be supported by appropriate information enabling users to understand, monitor and, where necessary, intervene in the operation of the device.

Or. en

Amendment 225

András Tivadar Kulja

Proposal for a regulation

Recital 59 d (new)

Text proposed by the CommissionAmendment
(59d) The increasing integration of advanced digital technologies, including artificial intelligence, into medical devices requires that users possess the knowledge and skills necessary for their safe and effective use. As medical devices may be operated, configured or overseen by healthcare professionals or other qualified personnel, depending on their intended purpose and use environment, manufacturers should provide appropriate information and resources to support user training and upskilling, thereby contributing to the safe deployment of such technologies and a high level of patient safety.

Or. en

Amendment 226

András Tivadar Kulja

Proposal for a regulation

Recital 59 e (new)

Text proposed by the CommissionAmendment
(59e) Without prejudice to the safety and performance requirements laid down in this Regulation, the design of medical devices should, where appropriate, contribute to the efficient use of resources and the reduction of environmental impacts throughout their lifecycle. Manufacturers should therefore be encouraged to develop reusable alternatives to single-use devices where this can be achieved without compromising patient safety or clinical performance, thereby supporting both the sustainability and resilience of healthcare systems.

Or. en

Amendment 227

Margarita de la Pisa Carrión

Proposal for a regulation

Article 1 – paragraph 1 – point 1 – point c

Regulation (EU) 2017/745

Article 1 – paragraph 6 – point g a (new)

Text proposed by the CommissionAmendment
Human foetuses and tissues or cells derived therefrom may not be the subject of actions aimed at bringing about their loss of viability for the purpose of classifying them as non-viable substances of human origin or of enabling their use as components of medical devices. Furthermore, obtaining, using or marketing human foetuses, including tissues or cells derived therefrom, shall be prohibited where they originate directly or indirectly from an induced abortion. Materials of foetal origin may only be used when not originating from an induced abortion and always in full respect of human dignity, fundamental ethical principles and applicable national law;

Or. es

Justification

La presente enmienda busca garantizar que la clasificación de una sustancia de origen humano como viable o inviable no pueda utilizarse para eludir las garantías éticas aplicables a materiales de origen fetal. Se pretende evitar que la pérdida deliberada de viabilidad pueda convertirse en un medio para facilitar su utilización como componente de productos sanitarios. Cualquier uso de materiales de origen fetal debe respetar la dignidad humana, los principios de no instrumentalización y la legislación nacional aplicable. Esta salvaguarda garantiza una adecuada protección del origen humano del material, independientemente de su procesamiento posterior.

Amendment 228

Margarita de la Pisa Carrión

Proposal for a regulation

Article 1 – paragraph 1 – point 1 – point c

Regulation (EU) 2017/745

Article 1 – paragraph 6 – point g b (new)

Text proposed by the CommissionAmendment
(ga) Human embryos, whether viable or non-viable, as well as tissues or cells derived therefrom, may not be used for any purpose, and are excluded from the scope of this Regulation. Under no circumstances are they to be considered medical devices, components of medical devices or materials to be used in the manufacture, incorporation or performance of a medical device, nor for use in its design, development, manufacture, assessment or marketing;

Or. es

Justification

La presente enmienda tiene por objeto garantizar una protección específica del embrión humano, evitando que pueda ser considerado un material biológico susceptible de ser incorporado, directa o indirectamente, a productos sanitarios. La exclusión expresa del embrión del ámbito de aplicación del Reglamento evita interpretaciones que pudieran permitir su utilización como componente o fuente de materiales para productos regulados. Esta salvaguarda garantiza el respeto de la dignidad humana, la no instrumentalización del ser humano en sus primeras fases de desarrollo y la aplicación de los principios éticos reconocidos por los Estados miembros.

Amendment 229

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 1 – point d a (new)

Regulation (EU) 2017/745

Article 1 – paragraph 8

Text proposed by the CommissionAmendment
(da) paragraph 8 is replaced by the following:
Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has a clinical action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.

Or. fr

Amendment 230

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 1 – point e – point ii

Regulation (EU) 2017/745

Article 1 – paragraph 10

Text proposed by the CommissionAmendment
(ii) in the second subparagraph, first sentence, the reference to ‘Directive 2004/23/EC’ is replaced by a reference to ‘Regulation (EU) 2024/1938’;(ii) in the second subparagraph, first sentence, is replaced by the following:
'However, if the action of those substances of human origine or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Regulation (EU) 2024/1938.'

Or. en

Amendment 231

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point d

Regulation (EU) 2017/745

Article 2 – point 48

Text proposed by the CommissionAmendment
– other clinical experience published in peer-reviewed scientific literature with the device concerned or a device for which equivalence to the device concerned can be demonstrated;– other clinical experience published particularly in peer-reviewed scientific literature with the device concerned or a device for which equivalence to the device concerned can be demonstrated;

Or. fr

Amendment 232

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point d

Regulation (EU) 2017/745

Article 2 – point 48

Text proposed by the CommissionAmendment
– other clinical experience published in peer-reviewed scientific literature with the device concerned or a device for which equivalence to the device concerned can be demonstrated;– other clinical experience published in scientific literature with the device concerned or a device for which equivalence to the device concerned can be demonstrated;

Or. en

Amendment 233

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point d

Regulation (EU) 2017/745

Article 2 – point 48

Text proposed by the CommissionAmendment
– clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;;– clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up, databanks and registries;

Or. en

Amendment 234

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point d

Regulation (EU) 2017/745

Article 2 – point 48

Text proposed by the CommissionAmendment
– clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;;– clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up, databanks and registries;

Or. en

Justification

Clearer reference to databanks and registries is needed, to make better use of such data.

Amendment 235

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72

Text proposed by the CommissionAmendment
(72) ‘well-established technology device’ means a device that belongs to a generic device group, which fulfils the following criteria:deleted
(a) it has simple, common and stable design;
(b) it has not been associated with safety issues in the past;
(c) it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art;
(d) it has a long history on the Union market;’;

Or. en

Justification

The definition is too vague. Instead, the Commission shall set an exhaustive list of technologies that it considers 'well-established.'

Amendment 236

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point a

Text proposed by the CommissionAmendment
(a) it has simple, common and stable design;(a) it has common and stable design;

Or. en

Amendment 237

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point a

Text proposed by the CommissionAmendment
(a) it has simple, common and stable design;(a) it has common and stable design;

Or. en

Justification

The current definition lacks precision, as "simple design" is not a measurable criterion.

Amendment 238

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point b

Text proposed by the CommissionAmendment
(b) it has not been associated with safety issues in the past;(b) it has a well-known safety history and, as defined by Article 87, has not been associated with safety issues in the past;

Or. en

Amendment 239

András Tivadar Kulja

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point b

Text proposed by the CommissionAmendment
(b) it has not been associated with safety issues in the past;(b) it has a well-known safety history and has not been associated with safety issues in the past as defined by Article 87;

Or. en

Amendment 240

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point b

Text proposed by the CommissionAmendment
(b) it has not been associated with safety issues in the past;(b) it has not been associated with safety issues in the past within the meaning of Article 87 of this Regulation;

Or. fr

Amendment 241

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point b

Text proposed by the CommissionAmendment
(b) it has not been associated with safety issues in the past;(b) it has not been associated with safety issues in the past as defined by Article 87 ;

Or. en

Amendment 242

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point b

Text proposed by the CommissionAmendment
(b) it has not been associated with safety issues in the past;(b) it has not been associated with any safety issues within the past 20 years;

Or. en

Amendment 243

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point b a (new)

Text proposed by the CommissionAmendment
(ba) it is supported by extensive post-market surveillance and vigilance data demonstrating a well-established safety and clinical performance profile;

Or. en

Amendment 244

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point c

Text proposed by the CommissionAmendment
(c) it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art;(c) it has well-known safety and clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art;

Or. en

Amendment 245

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point d

Text proposed by the CommissionAmendment
(d) it has a long history on the Union market;’;(d) it has been continuously marketed on the Union market for the duration of minimum 20 years;’;

Or. en

Amendment 246

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 72 – point d a (new)

Text proposed by the CommissionAmendment
(da) qualification as a well-established technology device must be based on objective and harmonised criteria that are applied uniformly throughout the Union.

Or. fr

Amendment 247

András Tivadar Kulja

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 a (new)

Text proposed by the CommissionAmendment
(76a) ‘Blood bag set‘ means sterile, disposable medical device, whether invasive or non-invasive, intended for the collection, processing, preparation, storage and transfusion of blood and blood components destined for administration to human individuals. Blood bag sets are closed systems comprising one or more plastic containers connected by integral components, including collection tubing, needles, filters, valves, clamps, attachments and other accessories, and may also contain one or more integrated solutions necessary to achieve their intended use.

Or. en

Amendment 248

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 a (new)

Text proposed by the CommissionAmendment
(76a) 'indirect clinical benefit' means a clinical benefit that arises from products whose intended purpose is not to deliver a specific therapeutic or diagnostic clinical benefit, but to enable or support medical procedures through technical, anatomical or other supporting functions.
For such products, safety and performance shall be demonstrated with regard to their intended purpose and claimed technical performance, having regard to the needs of the user, and not by reference to patient-related clinical endpoints.

Or. en

Amendment 249

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 a (new)

Text proposed by the CommissionAmendment
(76a) ‘breakthrough device’ means a novel medical device or in vitro diagnostic medical device expected to provide a significant positive clinical benefit through either of the following:
- Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art, or
- Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

Or. en

Amendment 250

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 a (new)

Text proposed by the CommissionAmendment
(76a) ‘connected device’ means an active device which intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network, based on the definitions: ‘logical connection’, ‘physical connection’ and ‘indirect connection’ included in article 3 of Regulation (EU) 2024/2847 of the European Parliament and of the Council.

Or. en

Amendment 251

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 a (new)

Text proposed by the CommissionAmendment
(76a) ‘specific cause’ means an assessment triggered by evidence of potential infringements, safety problems or quality problems involving serious potential danger or proven danger.

Or. fr

Amendment 252

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 b (new)

Text proposed by the CommissionAmendment
(76b) ‘Blood bag set‘ means sterile, disposable medical device, whether invasive or non-invasive, intended for the collection, processing, preparation, storage and transfusion of blood and blood components destined for administration to human individuals. Blood bag sets are closed systems comprising one or more plastic containers connected by integral components, including collection tubing, needles, filters, valves, clamps, attachments and other accessories, and may also contain one or more integrated solutions necessary to achieve their intended use.

Or. en

Justification

Blood bags are among the only medical devices that have been specifically named in the MDR's classification Annex, lacking dedicated definition in article 2. Introducing a clear, functional definition enhances legal certainty and ensures the term is applied consistently. A harmonised definition supports coherence with other Union legislation governing blood and blood components, particularly with the Regulation (EU) 2024/1938 on substances of human origin (SoHO), following the intention of Commission's proposal, ensuring that the device used to collect, process, store and administer blood is understood consistently across the medical device and SoHO frameworks. It likewise supports convergence with the terminology of the EDQM Guide to the preparation, use and quality assurance of blood components ("Blood Guide"), and should be drafted in a manner consistent with the EDQM's ongoing revision of that terminology, so as to avoid divergent definitions across interdependent instruments. A consistent definition further provides a stable reference point for the application of Union rules on material composition and chemical safety relevant to blood contact devices, including obligations arising under the broader chemicals framework, thereby reducing the risk of fragmented interpretation across regulatory regimes.

Amendment 253

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 b (new)

Text proposed by the CommissionAmendment
(76b) ‘blood bags’ means invasive and non-invasive devices intended for the sampling, treatment or storage of blood intended for administration to humans. These devices may or may not contain, as an integral element, one or more solutions to facilitate this intended use.

Or. fr

Amendment 254

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 b (new)

Text proposed by the CommissionAmendment
(76b) 'paediatric device’ means a medical devices intended for a use in the age group until 18 years of age. Further factors may need to be considered.

Or. en

Amendment 255

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 c (new)

Text proposed by the CommissionAmendment
(76c) ‘breakthrough device’ means a novel medical device or in vitro diagnostic medical device expected to obtain a significant clinical benefit through a substantial advancement over existing alternatives or by addressing an unmet medical need;

Or. fr

Amendment 256

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 d (new)

Text proposed by the CommissionAmendment
(76d) ‘orphan device’ means a medical device intended for a disease or condition affecting a maximum of 12 000 people per annum within the Union, within the meaning of Article 52 of this Regulation.

Or. fr

Amendment 257

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e

Regulation (EU) 2017/745

Article 2 – point 76 e (new)

Text proposed by the CommissionAmendment
(76e) ‘orphan in vitro diagnostic device’ means an in vitro diagnostic medical device intended to provide information about a disease or condition affecting a maximum of 5 in 10 000 people per annum within the Union.

Or. fr

Amendment 258

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e a (new)

Regulation (EU) 2017/745

Article 2 – point 76a (new)

Text proposed by the CommissionAmendment
(ea) the following point is added:
'breakthrough device' means any device expected to introduce in the Union a high degree of novelty with respect to the device technology, related clinical procedure or the application of the device in clinical practice and to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition by either of the following: (i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art; (ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

Or. en

Amendment 259

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e a (new)

Regulation (EU) 2017/745

Article 2 – paragraph 1 – point 5 – point a a (new)

Text proposed by the CommissionAmendment
(ea) With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union provided that all of the following conditions are met:

Or. en

Amendment 260

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e b (new)

Regulation (EU) 2017/745

Article 2 – point 76b (new)

Text proposed by the CommissionAmendment
(eb) the following point is added:
'orphan device' means any device intended for the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12 000 individuals in the Union per year and meeting at least one of the following criteria: (i) there are insufficient available alternatives; (ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art, taking into account both device-specific factors and patient population-specific factors.

Or. en

Justification

Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same challenges: small patient populations, limited clinical data, high development costs and low commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised conformity assessment and rolling review, preventing manufacturers from abandoning devices for children due to disproportionate regulatory burden.

Amendment 261

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point e c (new)

Regulation (EU) 2017/745

Article 2 – point 76c (new)

Text proposed by the CommissionAmendment
(ec) the following point is added:
'paediatric devices' means any device intended for the paediatric population as defined by Regulation 1901/2006 as persons ages between birth and 18 years.

Or. en

Amendment 262

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 2 a (new)

Regulation (EU) 2017/745

Article 2 – paragraph 1

Text proposed by the CommissionAmendment
(2a) 'Indirect clinical benefit' is achieved by products without an intended specific therapeutic or diagnostic clinical benefit. The benefit of these products relies on enablement or support of medical procedures by technical, anatomical and/or different supporting function according the users needs for the specific procedure. The safety and performance of these products is therefore not dedicated to patient-related endpoints but rather on the claimed e.g. technical purpose.

Or. en

Justification

Define Products with indirect clinical benefit to distinguish from products with direct clinical benefit and enable adequate demonstration of safety and performance for all those products that do not act in a direct ICD-based curative/diagnostic purpose but assists/enables such procedures.

Amendment 263

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 3 – paragraph 1

Text proposed by the CommissionAmendment
1. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of well-established technology device set out in Article 2, point (72), in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.deleted

Or. fr

Justification

This new category is an essential component of the review of the Regulation.

Amendment 264

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 3 – paragraph 2 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission may, by means of implementing acts, draw up non-exhaustive lists of devices that fall under, or of devices that do not fall under the definition of well-established technology device in Article 2, point (72).The Commission shall, by means of implementing acts, draw up an exhaustive list of devices that are considered well-established technology devices.

Or. en

Amendment 265

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 3 – paragraph 2 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission may, by means of implementing acts, draw up non-exhaustive lists of devices that fall under, or of devices that do not fall under the definition of well-established technology device in Article 2, point (72).The Commission may, following a consultation with the MDCG, by means of implementing acts, draw up non-exhaustive lists of devices that fall under, or of devices that do not fall under the definition of well-established technology device in Article 2, point (72).

Or. en

Amendment 266

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (UE) 2017/745

Article 3 – paragraph 2 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission may, by means of implementing acts, draw up non-exhaustive lists of devices that fall under, or of devices that do not fall under the definition of well-established technology device in Article 2, point (72).The Commission may, by means of implementing acts, draw up exhaustive lists of devices that fall under, or of devices that do not fall under the definition of well-established technology device in Article 2, point (72).

Or. fr

Amendment 267

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 1

Text proposed by the CommissionAmendment
1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category, or group of products, falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex.1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product that is already available on the market falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex.

Or. it

Justification

In line with the case law of the Court of Justice, the legal status of a product should be assessed on a case-by-case basis. The reference to a category or group of products should therefore be removed.

Amendment 268

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 1

Text proposed by the CommissionAmendment
1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category, or group of products, falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex.1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, already placed on the market falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex.

Or. en

Amendment 269

Sirpa Pietikäinen

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 2a (new)

Text proposed by the CommissionAmendment
2a. National competent authorities of the relevant sectorial legislation shall take into account the opinion of the relevant Union level advisory or regulatory bodies established in the Union legislation.
(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(See wording of Article 4, Regulation (EU) 2017/745.)

Amendment 270

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 3

Text proposed by the CommissionAmendment
3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, considers that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question.3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, and having regard to the provisions of paragraph 5a has substantiated evidence that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question.

Or. en

Amendment 271

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 3

Text proposed by the CommissionAmendment
3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, considers that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question.3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, and taking into account the provisions of paragraph 5a, has well-founded evidence that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question.

Or. it

Justification

Before calling into question the regulatory status of a device that is already available on the market, the competent authority must have well-founded evidence to justify its concerns about how that device should be classified.

Amendment 272

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 4

Text proposed by the CommissionAmendment
4. Where a competent authority of a Member State raises a substantiated disagreement regarding the envisaged measure referred to in paragraph 3, the consulting authority shall refer the matter to an expert panel as referred to in Article 106 and give utmost consideration to the opinion of that expert panel.4. The competent authorities of other Member States may submit an opinion within a maximum period of 90 days from the date of the referral. Where at least five competent authorities of Member States raise a substantiated disagreement regarding the envisaged measure referred to in paragraph 3, the expert panel as referred to in Article 106 shall be referred to and the competent authority of the Member State shall give utmost consideration to the opinion of that expert panel.

Or. fr

Amendment 273

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 5 a (new)

Text proposed by the CommissionAmendment
5a. For CE-marked products that have undergone an Article 52 conformity assessment with a notified body, the procedure referred to in this Article shall only apply if the competent authority in question has comprehensive evidence that the regulatory status of the product as a medical device poses an unacceptable risk pursuant to Article 94(a). The product’s regulatory status shall not, in and of itself, constitute such evidence.

Or. it

Justification

Before the regulatory status of a product that is already available on the market can be called into question, it is essential that clearly defined criteria regarding an unacceptable risk to patients are met. The overall aim here is to provide legal certainty for the European medical devices industry and reaffirm the central role of CE certificates as proof of product conformity. At all other events, a CE certificate should be regarded as a guarantee of a device’s conformity.

Amendment 274

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 5a (new)

Text proposed by the CommissionAmendment
5a. For products that are CE marked and for which the conformity assessment referred to in Article 52 involved a notified body, the procedure referred to in in this article shall apply only where the competent authority concerned has substantiated evidence that the qualification of the product as a medical device represents an unacceptable risk as referred to in Article 94, point (a). The regulatory qualification of the product shall not, in itself, constitute such evidence.

Or. en

Justification

To ensure legal certainty for the European medical device industry and to emphasize the key role of CE certificates as proof of product conformity, it is essential that clearly defined conditions related to an unacceptable risk to patients are fulfilled before the regulatory status of a product already placed on the market can be challenged. Otherwise, the presence of a CE certificate must be considered a guarantee of the device’s conformity.

Amendment 275

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 5 b (new)

Text proposed by the CommissionAmendment
5b. Having regard to the expert panel opinion referred to in Article 4(4), a Member State may submit a substantiated request to the Commission to determine whether a specific product falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. The Commission shall decide on the substantiated request of the Member State or on its own initiative, by means of implementing acts, which shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission may ask the expert panel for clarifications or refer the opinion back to the expert panel for further consideration, including in cases where a Member State's substantiated request raises new questions of a scientific or technical nature.

Or. it

Amendment 276

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 5b (new)

Text proposed by the CommissionAmendment
5b. Having regard to the expert panel opinion referred in Article 4(4), a Member State may submit a substantiated request to the Commission to determine whether a specific product falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. The Commission may decide on the substantiated request of the Member State or on its own initiative, by means of implementing acts, which shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission may ask the expert panel for clarifications or refer the opinion back to the expert panel for further consideration, including in cases where a Member State’s substantiated request raises new questions of a scientific or technical nature.

Or. en

Justification

Paragraph 5aa has been relocated from Article 4a(3), as it is considered that its application should be restricted to products that have already been placed on the market and certified, and should not extend to products still under development. For such products, responsibility for verifying the correct regulatory qualification lies with the competent authority of the Member State where the manufacturer has its registered place of business, in cases of disagreement between the manufacturer and the notified body. This amendment also aims to prevent intervention at Union level during an early stage, when the product’s technical characteristics and intended purpose have not yet been finalised.

Amendment 277

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 5c (new)

Text proposed by the CommissionAmendment
5c. When assessing whether a product may fall within a regulatory category other than that of medical devices, the competent authorities and the expert panel referred to in paragraph 4 of this Article shall give utmost consideration to whether the product concerned is capable to comply with the sector-specific legislation applicable to the category to which it is proposed to be assigned.
Where that category is that of medicinal products, particular attention shall be taken to assess, on the basis of the mechanism of action described by the manufacturer, whether the product could legally and practically obtain the relevant marketing authorisation. This assessment shall be carried out in order to ensure that any reclassification does not result in the loss of treatment options for patients.

Or. en

Amendment 278

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 5 c (new)

Text proposed by the CommissionAmendment
5c. Where such a product is deemed to have a different regulatory status following the coordination activities or subsequent regulatory assessment, any clinical or non-clinical data or data pertaining to post-market surveillance and vigilance and any other evidence of real-world use that was generated or collected during the period in which the product was lawfully placed on the market as a medical device shall remain admissible and may be taken into account for the purposes of a subsequent application or regulatory assessment, where relevant and scientifically valid.

Or. it

Justification

When assessing whether to assign a product with a different regulatory status to that of a medical device, the competent authority should consider the extent to which it can meet all of the applicable requirements. To that end, it should take into account both clinical and non-clinical data, as well as data pertaining to post-market surveillance, vigilance and the product’s use in real-world conditions when it was lawfully marketed as a medical device. In that context, products should not be reclassified in such a way as to make it impossible to market them.

Amendment 279

Laurent Castillo, Margarita de la Pisa Carrión, Ondřej Knotek, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 6

Text proposed by the CommissionAmendment
6. The Commission may, by means of implementing acts, lay down the procedure, including timelines, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).;6. The Commission may, by means of implementing acts, lay down the procedure, including timelines, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission shall consult stakeholders and Member States. ;

Or. fr

Amendment 280

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EU) 2017/745

Article 4 – paragraph 6

Text proposed by the CommissionAmendment
6. The Commission may, by means of implementing acts, lay down the procedure, including timelines, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).;6. The Commission shall, by means of implementing acts, lay down the procedure, including timelines and involvement of concerned stakeholders, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).;

Or. en

Amendment 281

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4a – paragraph 5 (new)

Text proposed by the CommissionAmendment
5. Any opinion of an expert panel relating to the determination of the regulatory status of a product shall be made publicly available, without disclosing confidential information in accordance with Article 109.

Or. en

Amendment 282

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4a – paragraph 1

Text proposed by the CommissionAmendment
1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.1. A competent authority, a notified body, the manufacturer or developer of the product concerned, provided that it is responsible for the development or placing on the market of that product, or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.

Or. en

Amendment 283

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4 a – paragraph 1

Text proposed by the CommissionAmendment
1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.1. A competent authority may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.

Or. it

Justification

These coordination activities should only apply to medical devices that have not been CE marked or made available on the market. Devices that are already on the market are governed by Article 4. Limiting the scope of these activities will make it possible to resolve classification issues prior to certification, and ultimately provide greater legal certainty and predictability. The procedure should only be initiated by the competent authorities. There should be no direct involvement of other parties, least of all the developer, which the regulation fails to define.

Amendment 284

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4a – paragraph 1

Text proposed by the CommissionAmendment
1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.1. A competent authority may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.

Or. en

Justification

The proposed mechanism should apply only to medical devices that have not yet obtained CE certification and have not yet been placed on the market, as products already on the market are covered by the provisions of Article 4.

This limitation is necessary to ensure that regulatory qualification issues are resolved during the pre-certification stage, thereby enhancing legal certainty and predictability for all stakeholders.

The authority to initiate the procedure should remain exclusively with the competent authorities, excluding any direct involvement of other parties (including developers, who are not defined by the Regulation), in order to safeguard the mechanism’s impartiality, proportionality, and intended purpose.

Amendment 285

Sirpa Pietikäinen

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4a – paragraph 1

Text proposed by the CommissionAmendment
1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 to confirm the mode of action, where necessary and on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII.
(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(See wording of the new Article 4a, Regulation (EU) 2017/745.)

Amendment 286

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4a – paragraph 2

Text proposed by the CommissionAmendment
2. The expert panel shall provide its opinion without undue delay. The requester shall give utmost consideration to the opinion of the expert panel.2. The expert panel shall provide its opinion without undue delay and within a period of 90 days from the date of receipt of a complete application, unless there are properly justified scientific or technical reasons that necessitate an extension. The requester shall give utmost consideration to the opinion of the expert panel. Where the opinion relates to an application submitted by a third party, the manufacturer or developer of the product in question shall have the opportunity to submit comments before the opinion becomes definitive.

Or. fr

Amendment 287

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 2017/745

Article 4a – paragraph 3 – subparagraph 4 (new)

Text proposed by the CommissionAmendment
Where the regulatory status of a product or category of products has already been determined under this Regulation or established prior to its date of entry into force, that status shall remain in effect unless there is new scientific or technical evidence showing that the criteria for that decision are no longer fulfilled.

Or. fr

Amendment 288

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point i – point 1

Regulation (EU) 207/745

Article 5 – paragraph 5 – point a

Text proposed by the CommissionAmendment
(a) the devices are not transferred to another legal entity, except to another health institution in the duly justified interest of public health, patient safety or patient health, or to prepare or respond to a public health emergency;;(a) the devices are not transferred to another legal entity, except to another health institution in response to a declared public health emergency, and only for the duration of that emergency;

Or. en

Amendment 289

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point i – point 2

Regulation (Eu) 2017/745

Article 5 – paragraph 5 – point d

Text proposed by the CommissionAmendment
(d) upon request by a competent authority, the health institution provides information upon request on the use of such devices, which includes the justification referred to in points (a) and (c);;(d) the health institution registers the device in EUDAMED prior to clinical use, including the clinical purpose, the equivalence assessment, declared institutional and individual economic interests (including IP ownership and spin-out arrangements), and the outcome of a market consultation conducted via TED or equivalent national procurement platforms;

Or. en

Amendment 290

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point i – point 3

Regulation (EU) 2017/745

Article 5 – paragraph 5 – point f

Text proposed by the CommissionAmendment
(f) the health institution draws up documentation that is sufficiently detailed to enable the competent authority to ascertain that the relevant general safety and performance requirements set out in Annex I are met;;(f) the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;

Or. en

Amendment 291

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point i – point 4

Regulation (EU) 2017/745

Article 5 – paragraph 5 – point g

Text proposed by the CommissionAmendment
(4) point (g) is deleted;deleted

Or. en

Amendment 292

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point i a (new)

Regulation (EU) 2017/745

Article 5 – paragraph 5 – subparagraph 1a (new)

Text proposed by the CommissionAmendment
(ia) The following subparagraph is added:
The transfer of devices manufactured and used in accordance with Article 5(5) between health institutions established in the Union shall be permitted only where: (a) the receiving health institution complies with the conditions laid down in Article 5(5); (b) the traceability of the device, including its manufacture, transfer and use, is ensured throughout its lifecycle; (c) the quality management system under which the device was manufactured and is used is maintained and documented by the transferring and receiving health institutions; and (d) the transfer does not prevent the competent authorities of the Member States concerned from exercising effective supervision, including access to the documentation necessary to verify compliance with this Regulation and the power to carry out inspections and require corrective measures, where appropriate.

Or. en

Justification

The conditions governing such transfers should be specified more clearly to ensure a consistent application of this Regulation. In particular, transfers should not compromise traceability, quality management or the ability of competent authorities to verify compliance through effective supervision and inspections. Clear conditions are necessary to maintain a high level of patient safety while providing legal certainty for health institutions and supervisory authorities

Amendment 293

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point ii

Regulation (EU) 2017/745

Article 5 – subparagraph 2

Text proposed by the CommissionAmendment
Member States shall retain the right to restrict the manufacture or the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.;Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.

Or. en

Amendment 294

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point iii

Regulation (EU) 2017/745

Article 5 – paragraph 5 – subparagraph 4

Text proposed by the CommissionAmendment
For the purposes of the first subparagraph, point (c), from the date that the health institution becomes aware that the target patient group's specific needs can be met by a device available on the market, it may continue to manufacture and use its device for a maximum period of 10 years.For the purposes of the first subparagraph, point (c), from the date that the health institution becomes aware, or reasonably ought to have become aware through a mandatory six-monthly market reassessment, that the target patient group's specific needs can be met by a device available on the market the exemption shall lapse within six months;

Or. en

Amendment 295

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point iii

Regulation (EU) 2017/745

Article 5 – paragraph 5 – subparagraph 6a

Text proposed by the CommissionAmendment
The following subparagraph is added:
Devices manufactured under this exemption shall not be used for more than 500 patients per year per device per institution. Use exceeding this threshold requires full CE marking;

Or. en

Amendment 296

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point a – point iii

Regulation (EU) 2017/745

Article 5 – paragraph 5 – subparagraph 6b

Text proposed by the CommissionAmendment
The following subparagraph is added:
Exemptions under this Article shall be granted by the competent authority of the Member State upon prior application, not by self-declaration. The application shall include the documentation referred to in point (d).’;

Or. en

Amendment 297

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraphs 7 and 8

Text proposed by the CommissionAmendment
(b) the following paragraphs 7 and 8 are added:deleted
‘7. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments or to add requirements in relation to emerging risks or technologies.
8.
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.
*** Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).;’

Or. en

Amendment 298

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b – introductory part

Regulation (EU) 2017/745

Text proposed by the CommissionAmendment
(b) the following paragraphs 7 and 8 are added:(b) the following paragraph 7 is added:

Or. en

Amendment 299

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments or to add requirements in relation to emerging risks or technologies.deleted

Or. fr

Justification

These are essential elements that should not be capable of amendment by delegated acts.

Amendment 300

Jessica Polfjärd

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments or to add requirements in relation to emerging risks or technologies.7. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments or to add relevant requirements in relation to emerging risks or technologies.

Or. en

Amendment 301

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
8. When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.deleted
*** Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).;

Or. en

Amendment 302

Tomislav Sokol

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall include the requirements set out in Chapter III, Section 2, of that Regulation, particularly in regard to human oversight as well as the obligations of the deployer of high-risk AI systems, so that the same level of patient safety is ensured.

Or. en

Amendment 303

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.The Commission shall adopt implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, and the Commission shall ensure that the requirements set out in Chapter III, Section 2, of that Regulation are fully integrated into and complied with under this regulation.

Or. en

Amendment 304

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/745

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.When adopting implementing acts pursuant to paragraph 6 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.

Or. fr

Amendment 305

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 6 – point b

Regulation (EU) 2017/745

Article 6 – paragraph 4

Text proposed by the CommissionAmendment
4. A Member State may, on grounds of protection of public health, require a provider of a service as defined in Article 1(1), point (b), of Directive (EU) 2015/1535, or a provider of a service in accordance with paragraph 2, to cease its activity.;4. A Member State may, on grounds of protection of public health, patient safety or consumer protection, require a provider of a service as defined in Article 1(1), point (b), of Directive (EU) 2015/1535, or a provider of a service in accordance with paragraph 2, to cease its activity. Where the Member Sate makes such a request, it shall be communicated through EUDAMED, without undue delay.

Or. en

Amendment 306

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EU) 2017/745

Article 7 – paragraph 2

Text proposed by the CommissionAmendment
‘Without prejudice to national law regarding the exercise of the medical profession, the first subparagraph shall also apply to devices used for the provision of a service referred to in Article 6(2).’;‘Without prejudice to national law regarding the exercise of the medical profession, the first subparagraph shall also apply to devices used for the provision of a service referred to in Article 6(2). For the purposes of implementing this Article, and in the interests of preventing obstacles to the free movement of goods within the Union, Member States shall not introduce or maintain preventive control or authorisation systems for the advertising of devices. Member States shall retain the power to act retrospectively, including proscribing or imposing penalties on advertising practices that fail to comply with the requirements of this Article, in accordance with Union and national law.’

Or. it

Justification

This amendment seeks to maintain harmonised EU rules on advertising and claims for medical devices, while eschewing national pre-authorisation or notification systems liable to fragment the single market. A single framework would help to reduce administrative burdens, ensure that Article 7 would continue to apply in the post-marketing phase, and provide more consistent checks. This would limit the number of divergent interpretations and reduce unfair competition.

Amendment 307

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EU) 2017/745

Article 9 – paragraph 1a (new)

Text proposed by the CommissionAmendment
1a. The Commission, in collaboration with the MDCG and, where appropriate, the expert panels referred to in Article 106, shall periodically identify and publish categories of devices for which common specifications are needed to address one or more of the following:
(a) documented, material and recurring divergence in the conformity assessment of comparable devices within the same device category, across notified bodies or authorities responsible for notified bodies in different Member States, including divergences in certificate outcomes, certificate restrictions, clinical or technical evidence requirements, or post-market clinical follow-up obligations;
(b) significant safety or performance concerns identified through post-market surveillance, vigilance data or published scientific evidence that harmonised criteria could reasonably address;
(c) the absence, or insufficient specificity, of harmonised standards or other harmonised criteria addressing the specific risks, performance characteristics, intended purpose, conditions of use or intended users of a defined category of devices, where device-specific requirements are necessary to ensure consistent and adequate demonstration of conformity with the regulation.
Where a category of devices is identified pursuant to the first subparagraph, the Commission shall prioritise the development and adoption of common specifications pursuant to paragraph 1. Such common specifications shall, as appropriate, include measurable thresholds for accuracy, reliability and clinical performance; requirements for the nature, quality and extent of clinical evidence required to demonstrate conformity, including, where appropriate, requirements relating to clinical investigation or Post-market clinical follow-up (PMCF) study design, endpoints, comparator criteria, target populations, follow-up duration and statistical methodology, proportionate to the device, its risk class and its intended purpose; and post-market surveillance and post-market clinical follow-up requirements tailored to the category concerned. The Commission shall report annually to the European Parliament and the Council on the categories of devices identified pursuant to this paragraph and on the progress of the development of associated common specifications.

Or. en

Amendment 308

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EU) 2017/745

Article 10 – paragraph 9

Text proposed by the CommissionAmendment
The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.;The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
For the purposes of demonstrating compliance with the quality management system requirements of this Regulation, manufacturers may use the results of audits undertaken in the context of internationally recognised programmes such as ISO certification No 13485 and the Medical Device Single Audit Program (MDSAP).

Or. it

Justification

This amendment seeks to ensure that notified bodies take account of the certifications of ISO standard No 13485 and the Medical Device Single Audit Program when assessing the quality management system. Recognising these certifications would help to prevent duplicated audits and superfluous documentation, and would alleviate administrative burdens without compromising on safety. It would also enable resources to be targeted to areas of greater risk and added value.

Amendment 309

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EU) 2017/745

Article 10 – paragraph 9 – subparagraph 2a (new)

Text proposed by the CommissionAmendment
Notified Bodies shall rely on relevant results from audits or certifications carried out under internationally recognised quality management schemes, including ISO 13485 and the Medical Device Single Audit Program (MDSAP), where such results are suitable to demonstrate compliance with the quality management system requirements and GSPRs of this Regulation.

Or. en

Amendment 310

András Tivadar Kulja

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point c

Regulation (EU) 2017/745

Article 10 – paragraph 10

Text proposed by the CommissionAmendment
(c) paragraph 10 is deleted;(c) deleted

Or. en

Amendment 311

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point d

Regulation (EU) 2017/745

Article 10 – paragraph 11

Text proposed by the CommissionAmendment
(d) in paragraph 11, the following subparagraph is added:deleted
‘When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).;’

Or. en

Amendment 312

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point d

Regulation (EU) 2017/745

Article 10 – paragraph 11

Text proposed by the CommissionAmendment
(d) in paragraph 11, the following subparagraph is added:deleted
‘When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).;’

Or. en

Justification

The intended user may not necessarily be a medical professional, but may be a patient, and in any case language skills of medical professionals may also vary. A language commonly used in a Member State would likely be more accessible, and in any case the Member State is already empowered to make this choice.

Amendment 313

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point d

Regulation (EU) 2017/745

Article 10 – paragraph 11

Text proposed by the CommissionAmendment
When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).’;When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available in accordance with any language-related national provisions, Member States may consider accepting another official language of the Union in which the information is made available, following a rigorous assessment of the technical knowledge, experience, education or training and practical language experience of the average intended professional user(s), so that the health of patients and the safety and working conditions of operators and professionals are always prioritised and guaranteed’;

Or. fr

Justification

In France, the official language has been French since publication of the Ordinance of Villers-Cotterêt in 1539, during the reign of Francis I. Making medical devices available, even if they are restricted to professionals, in any language other than French would be incompatible with the Toubon Law of 1994, Article 2 of which provides that ‘the use of the French language shall be mandatory in the designation, supply, presentation, method of use, scope description and guarantee conditions of a good, product or service [...]’.

Amendment 314

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point d

Regulation (EU) 2017/745

Article 10 – paragraph 11

Text proposed by the CommissionAmendment
When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).;When determining the official language(s) of the Union in which the information referred to in Section 23 of Annex I or other information provided by the manufacturer is to be made available, Member States shall consider accepting one or more official language(s) of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).

Or. en

Amendment 315

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point e

Regulation (EU) 2017/745

Article 10 – paragraph 13

Text proposed by the CommissionAmendment
(e) paragraph 13 is deleted;deleted

Or. fr

Amendment 316

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point e

Regulation (EU) 2017/745

Article 10 – paragraph 13

Text proposed by the CommissionAmendment
(e) paragraph 13 is deleted;deleted

Or. en

Amendment 317

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point f

Regulation (EU) 2017/745

Article 10 – paragraph 14

Text proposed by the CommissionAmendment
(f) paragraph 14 is amended as follows:deleted
(i) the third subparagraph is deleted;
(ii) the fourth subparagraph is deleted;

Or. en

Justification

The texts concerned here give the competent authority the obligation to facilitate patient access to documentation, where a competent authority believes the patient may be potentially injured by a certain device. These texts should be maintained to ensure continued access to information for patients.

Amendment 318

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point f

Regulation (EU) 2017/745

Article 10 – paragraph 14

Text proposed by the CommissionAmendment
(f) paragraph 14 is amended as follows:deleted
(i) the third subparagraph is deleted;
(ii) the fourth subparagraph is deleted;

Or. fr

Amendment 319

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point f – point i

Regulation (EU) 2017/745

Article 10 – paragraph 14

Text proposed by the CommissionAmendment
(i) the third subparagraph is deleted;deleted

Or. en

Amendment 320

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point f – point ii

Regulation (EU) 2017/745

Article 10 – paragraph 14

Text proposed by the CommissionAmendment
(ii) the fourth subparagraph is deleted;deleted

Or. en

Amendment 321

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point h

Regulation (EU) 2017/745

Article 10 – paragraph 16

Text proposed by the CommissionAmendment
(h) paragraph 16 is deleted;(h) paragraph 16 is replaced by the following:
'Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive (EU) 2024/2853, without prejudice to more protective measures under national law;'

Or. en

Amendment 322

András Tivadar Kulja

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point h a (new)

Regulation (EU) 2017/745

Article 10 – paragraph 16a (new)

Text proposed by the CommissionAmendment
(ha) Liability insurance
Manufacturers, importers, authorised representatives or other economic operators liable under Article 8 of Directive (EU) 2024/2853 (1) shall ensure that they have adequate liability insurance covering all damage to patients or users for their potential liability under Article 8 of Directive (EU) 2024/2853 (1), before placing medical devices on the market, putting them into service or making them available.

Or. en

Amendment 323

Ondřej Dostál

Proposal for a regulation

Article 1 – paragraph 1 – point 9 a (new)

Regulation (EU) 2017/745

Article 10 – paragraph 9 – subparagraph 2a (new)

Text proposed by the CommissionAmendment
(9a) Notified bodies have to consider relevant results from audits or certifications carried out under internationally recognised quality management schemes, including ISO 13485 and the Medical Device Single Audit Program (MDSAP), where such results are suitable to demonstrate compliance with the quality management system requirements of this Regulation.

Or. en

Justification

Amendment 29 should clarify that this is the responsibility of NBs, not manufacturers.

Amendment 324

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point a

Regulation (EU) 2017/745

Article 10a – paragraph 1

Text proposed by the CommissionAmendment
The information referred to in the first subparagraph shall be provided at least six months before the anticipated interruption or discontinuation or, if this is not possible, without undue delay after the manufacturer becomes aware of the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.;The information referred to in the first subparagraph shall be provided at least six months before the anticipated interruption or discontinuation or, where this is not possible, immediately after becoming aware of the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority in accordance with Annex XVIII. Where the information initially provided changes, the manufacturer shall submit an updated notification without undue delay. The manufacturer shall notify the competent authority without undue delay upon the resumption of normal supply.

Or. en

Amendment 325

Andreas Glück

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point a a (new)

Regulation (EU) 2017/745

Article 10a – paragraph 1 – subparagraph 1

Present textAmendment
(aa) In Article 10a paragraph 1, the first subparagraph is replaced by the following:
Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation."Where a manufacturer anticipates a discontinuation of the supply of a device, other than a custom-made device, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established by entering the discontinuation date to EUDAMED. The economic operators, health institutions and healthcare professionals to whom it directly supplies the device, are to be informed of the anticipated discontinuation in a timely manner to enable their input towards the Executive Steering Group on Shortages of Medical Devices (MDSSG)."

Or. en

(Regulation (EU) 2017/745)

Justification

While early notification of supply interruptions is supported, the current text introduces disproportionate reporting obligations inconsistent with the revision's simplification objective. Mandatory disclosure of production capacities, sales volumes and supply chain structures exposes commercially sensitive information, weakening European manufacturers' competitiveness without improving patient safety. Notification via EUDAMED suffices. Manufacturers cannot reasonably report complex global upstream supply chains largely outside their control.

Amendment 326

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point a a (new)

Regulation (EU) 2017/745

Article 10a – paragraph 2

Present textAmendment
The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated interruption or discontinuation of supply."The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated interruption, discontinuation or resumption of supply."

Or. en

(Regulation (EU) 2017/745)

Amendment 327

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.4. The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33, and information on interruptions and discontinuations shall be accessible for patients and healthcare professionals. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.

Or. en

Amendment 328

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.4. The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33. It shall also enable health institutions, healthcare professionals, patients, and patients and consumer organisations to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.

Or. en

Amendment 329

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.4. The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage a publicly available IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33. It shall also enable health institutions, patients, and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices.

Or. en

Amendment 330

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 5

Text proposed by the CommissionAmendment
5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission, shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.5. ​The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology based on objective and transparent criteria to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could affect the availability of devices and result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission, shall draw up, publish and keep under continuous review and update, where needed, a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers shall be consulted, where necessary.

Or. en

Amendment 331

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 5

Text proposed by the CommissionAmendment
5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission, shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG, healthcare professionals, patients and the expert panels, and in agreement with the Commission, shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.

Or. en

Amendment 332

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 5

Text proposed by the CommissionAmendment
5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission, shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission, shall draw up, publish and keep up to date a non-exhaustive list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers shall be consulted.

Or. en

Amendment 333

Andreas Glück

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 6

Text proposed by the CommissionAmendment
6. The competent authorities of the Member States or the Commission may request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales.;deleted

Or. en

Amendment 334

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 6

Text proposed by the CommissionAmendment
6. The competent authorities of the Member States or the Commission may request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales.;deleted

Or. en

Amendment 335

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 6

Text proposed by the CommissionAmendment
6. The competent authorities of the Member States or the Commission may request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales.;6. ​The competent authorities of the Member States or the Commission shall request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks, vulnerabilities and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales and measures taken or planned to mitigate any interruption or discontinuation of supply.

Or. en

Amendment 336

Aurelijus Veryga, Tomislav Sokol

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b a (new)

Regulation (EU) 2017/745

Article 10 a – paragraph 6a (new)

Text proposed by the CommissionAmendment
(ba) the following paragraph is added:
Where the Commission, the Agency or the competent authorities identify that the implementation or proposed implementation of another Union legislative act is reasonably expected to result in the interruption or discontinuation of the supply of devices referred to in this Article, the Commission shall, in cooperation with the MDSSG and the EMA, assess:
(a) the likely impact on continuity of patient care and public health;
(b) the availability and technical feasibility of suitable alternative materials, substances, technologies or devices;
(c) the time necessary to redesign, validate and complete any conformity assessment required under this Regulation for replacement devices; and
(d) whether appropriate transitional measures or other proportionate regulatory solutions are necessary to safeguard the continued availability of such devices until suitable alternatives can be safely placed on the Union market.

Or. en

Amendment 337

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b a (new)

Regulation (EU) 2017/745

Article 10a – paragraph 6a (new)

Text proposed by the CommissionAmendment
(ba) the following paragraph is added:
'Based on the reporting and received information referred to in paragraphs 1, 2, 3 and 4, the competent authorities shall ensure that information on actual and anticipated interruptions or discontinuations of the supply of devices, as assessed by those authorities, is made publicly available through the IT system referred to in paragraph 4 and is kept up to date. The information shall be presented in a user-friendly and easily searchable format, taking into account the protection of commercially confidential information.'

Or. en

Amendment 338

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 10 a (new)

Regulation (EU) 2017/745

Article 10a – paragraphs 1, 2 and 3

Text proposed by the CommissionAmendment
(10a) In Article 10a, paragraphs 1, 2 and 3 are replaced by the following:
"
1. Where a manufacturer anticipates a discontinuation of the supply of a device, other than a custom-made device, it shall inform the competent authority of the Member State where it or its authorised representative is established by entering the discontinuation date to EUDAMED.
Moreover, economic operators, health institutions and healthcare professionals to whom it directly supplies the device, shall be informed of the anticipated discontinuation without undue delay, to enable them to alert the competent authorities to the immediate risk of unavailability of devices needed for the exercise of their professional activity in accordance with paragraph 4, and to provide information to the Executive Steering Group on Shortages of Medical Devices (MDSSG).
2. The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated discontinuation.
3. The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated discontinuation.
"

Or. en

Amendment 339

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 10 a (new)

Regulation (EU) 2017/745

Article 10a – paragraph 3

Present textAmendment
(10a) the paragraph 3 is replaced by the following:
The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated interruption or discontinuation."The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated interruption, discontinuation or resumption of normal supply."

Or. en

(Regulation (EU) 2017/745)

Amendment 340

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 11

Regulation (EU) 2017/745

Article 11 – paragraphs 4 and 5

Text proposed by the CommissionAmendment
(11) in Article 11, paragraphs 4 and 5 are deleted;deleted

Or. fr

Amendment 341

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 11

Regulation (EU) 2017/745

Article 11 – paragraphs 4 and 5

Text proposed by the CommissionAmendment
(11) in Article 11, paragraphs 4 and 5 are deleted;deleted

Or. en

Amendment 342

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 11 a (new)

Regulation (EU) 2017/745

Article 13 – paragraph 2

Present textAmendment
Article 13(2)‘Article 13(2)
2. In order to place a device on the market, importers shall verify that:2. In order to place a device on the market, importers shall demonstrate that:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;(b) a manufacturer and authorised representative, if applicable, can be identified;
(c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;(c) the device is accompanied by a physical and/or digital label and the instructions for use;
(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.(d) where applicable, a UDI has been assigned by the manufacturer.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorised representative.For the purposes of complying with the requirements of points (a) to (d) hereof, the importer may use the documentation provided with the device or a sampling method that is based on the particular risk class of the devices they are importing.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorised representative.’

Or. it

((EU) 2017/745)

Justification

The proposed amendments to Articles 13 and 14 clarify that importers and distributors need to ascertain, on the basis of the documentation provided, the CE marking and required documentation, without re-evaluating the conformity of the device. Such quality assurance will provide more guarantees than physical inspection alone. In the interests of harmonising requirements and alleviating the administrative burden, risk-based sampling should apply to both of these methods.

Amendment 343

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 11 a (new)

Regulation (EU) 2017/745

Article 13 – paragraph 2

Present textAmendment
(11a) in Article 13, paragraph 2 is amended as follows:
2. In order to place a device on the market, importers shall verify that:"2. In order to place a device on the market, importers shall have the evidencey that:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;(b) a manufacturer and an authorised representative if applicable, are identified;
(c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;(c) the device has a physical or digital label in accordance with this Regulation and accompanied by the required instructions for use;
(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.(d) where applicable, a UDI has been assigned by the manufacturer.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.To verify compliance with points (a) to (d) of the first subparagraph, importers may rely on the documentation supplied with the device or apply risk-based sampling methods taking into account the risk class of the devices they import. Where an importer has reason to believe that a device is not in conformity with this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative. Where the importer has reason to believe that the device presents a serious risk or is falsified, it shall also inform the competent authority of the Member State in which it is established."

Or. en

(Regulation (EU) 2017/745)

Amendment 344

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 11 b (new)

Regulation (EU) 2017/745

Article 13 – paragraph 2

Present textAmendment
(11b) in Article 13, paragraph 2 is amended as follows:
2. In order to place a device on the market, importers shall verify that:(a)the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(b)a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;(c)the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;(d)where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established."2. In order to place a device on the market, importers shall have the evidence that:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) a manufacturer and an authorised representative if applicable, are identified;
(c) the device has a physical or digital label in accordance with this Regulation and accompanied by the required instructions for use;
(d) where applicable, a UDI has been assigned by the manufacturer.
To verify compliance with points (a) to (d) of the first subparagraph, importers may rely on the documentation supplied with the device or apply risk-based sampling methods taking into account the risk class of the devices they import. Where an importer has reason to believe that a device is not in conformity with this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative. Where the importer has reason to believe that the device presents a serious risk or is falsified, it shall also inform the competent authority of the Member State in which it is established."

Or. en

(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&qid=1784813355735)

Justification

The purpose of the amendment is to ensure consistency with the changes proposed to Article 13(2) of the IVDR by the SANT rapporteur. Article 13(2) of both the MDR and the IVDR does not expressly state that importers may fulfil their verification obligations by applying a representative sampling method. By contrast, Article 14(2) allows such an approach for distributors.

This creates regulatory inconsistency and imposes disproportionate burdens on importers, particularly where large volumes of devices are involved, without clearly improving the level of safety.

Article 13(2) of both the IVDR and the MDR should therefore be supplemented with a provision allowing importers to use a representative sampling method, in line with the approach already provided for distributors.

Amendment 345

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 12 a (new)

Regulation (EU) 2017/745

Article 14 – paragraph 2

Present textAmendment
Article 14(2)‘Article 14(2)
2. Before making a device available on the market, distributors shall verify that all of the following requirements are met:2. Before making a device available on the market, distributors shall demonstrate that all of the following requirements are met:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);(b) the device is accompanied by the label and instructions for use;
(c) for imported devices, the importer has complied with the requirements set out in Article 13(3);(c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
‘(d) that, where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27(3).’;‘(d) that, where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27(3).’;
‘In order to meet the requirements referred to in the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.’;‘In order to meet the requirements referred to in the first subparagraph the distributor may use the documentation provided with the device or apply a sampling method that is based on the risk class and representative of the devices supplied by that distributor.’;

Or. it

((EU) 2017/745)

Justification

See the equivalent justification for Article 13.

Amendment 346

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 13 – point a

Regulation (EU) 2017/745

Article 15 – paragraph 1

Text proposed by the CommissionAmendment
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.;1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Or. en

Amendment 347

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 13 – point a

Regulation (EU) 2017/745

Article 15 – paragraph 1

Text proposed by the CommissionAmendment
‘1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.’;‘1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacology, engineering or other relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems for medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems for medical devices.’;

Or. it

Justification

In the interests of ensuring expertise, vigilance and accountability, it is vital that the training and experience requirements for persons responsible for regulatory compliance under the MDR and IVDR are retained. Doing away with these requirements would not simplify the legislative framework. Rather, it would increase the risk of compliance breaches and divergent national regimes, not least in Italy, where these individuals have specific responsibilities and are liable to incur penalties. Basic qualification requirements should not be sacrificed for the sake of affording greater flexibility to SMEs.

Amendment 348

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 13 – point b

Regulation (EU) 2017/745

Article 15 – paragraph 2

Text proposed by the CommissionAmendment
Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal.Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal. The manufacturer shall establish a binding, written agreement with the external person responsible for regulatory compliance, which explicitly defines their technical and legal availability, including a maximum response time of 48 hours in the event of vigilance reporting, safety corrective actions, or requests from competent authorities.

Or. en

Amendment 349

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 13 – point b

Regulation (EU) 2017/745

Article 15 – paragraph 2

Text proposed by the CommissionAmendment
Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal.Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal at all times .

Or. en

Amendment 350

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 13 – point d

Regulation (EU) 2017/745

Article 15 – paragraph 6

Text proposed by the CommissionAmendment
6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements or medical devices in the Union.;6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements or medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Or. en

Amendment 351

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 14 – point a a (new)

Regulation (EU) 2017/745

Article 16 – paragraph 3

Text proposed by the CommissionAmendment
(aa) paragraph 3 is deleted

Or. en

Amendment 352

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 14 – point b

Regulation (EU) 2017/745

Article 16 – paragraph 4

Text proposed by the CommissionAmendment
(b) paragraph 4 is deleted;(b) paragraph 4 is replaced by the following:
'At least 28 days prior to making the relabelled, refurbished or repackaged device available on the market, distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they intend to make the device available of their intention to place the relabelled, refurbished or repackaged device on the market. Within the same period of 28 days, the competent authority may, where it considers it necessary, require the distributor or importer to submit a certificate, issued by a notified body designated for the type of devices subject to the activities referred to in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3.'

Or. en

Amendment 353

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 14 – point b

Regulation (EU) 2017/745

Article 16 – paragraph 4

Text proposed by the CommissionAmendment
(b) paragraph 4 is deleted;(b) paragraph 4 is amended as follows:
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer of their intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.

Or. it

Justification

Transparency requirements for operators that relabel or repackage medical devices should be maintained. Even if these activities are not such as to make the operator tantamount to a manufacturer, the original manufacturer should be able to identify and monitor any changes that affect traceability, performance and post-market surveillance. Timely information is essential to maintain the integrity of the supply chain and protect patient safety.

Amendment 354

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 14 – point b

Regulation (EU) 2017/745

Article 16 – paragraph 4

Text proposed by the CommissionAmendment
(b) paragraph 4 is deleted;(b) paragraph 4 is amended as follows:
At least 28 days prior to placing the relabelled or repackaged device on the market, distributors or importers carrying out one of the activities given in points (a) and (b) of paragraph 2 shall notify the manufacturer of their intention to place the relabelled or repackaged device on the market and shall, upon request, provide the manufacturer with a sample or mock-up of the relabelled or repackaged device, including all translated labelling and instructions for use.

Or. fr

Amendment 355

Jessica Polfjärd

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17

Text proposed by the CommissionAmendment
(15) Article 17 is replaced by the following:deleted
‘Article 17
Single-use devices and reprocessing of devices that are not for single use
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.
2. If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.;’

Or. en

Amendment 356

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – title

Text proposed by the CommissionAmendment
Single-use devices and reprocessing of devices that are not for single useSingle-use devices, reprocessing and full refurbishment of medical devices

Or. en

Amendment 357

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – title

Text proposed by the CommissionAmendment
Single-use devices and reprocessing of devices that are not for single useSingle-use devices and reprocessing of devices.

Or. en

Amendment 358

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. The manufacturer shall be responsible for specifying whether a device is intended for single-use or can be reprocessed. This information shall be included in the technical documentation referred to in Annex II.

Or. it

Justification

It should not be automatically assumed that a device can be reprocessed. That assessment, which should remain the preserve of the manufacturer, should take into account a number of factors, including the product characteristics and use context. It should therefore continue to be up to the manufacturer to specify whether a device should be considered single-use or can be reprocessed – and if so, how.

Amendment 359

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. A device shall be intended for single-use where the manufacturer markets it under that indication. The manufacturer’s indication of single use shall be part of the technical documentation referred to in Annex II.

Or. fr

Amendment 360

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II. The manufacturer’s justification for designating a device as single-use shall be subject to assessment by the notified body as part of the conformity assessment, in accordance with the Common Specifications adopted by the Commission as provided by paragraph 4

Or. en

Justification

Single-use devices are needed in certain circumstances. However, there can be clear incentive to make a product single-use where this is not in fact medically appropriate (but may be e.g. economically advantageous). To resolve this, the manufacturer should justify, and the notified body assess, why a product needs to be a single use device.

Amendment 361

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. The manufacturer shall be responsible for indicating whether a device is intended for single use or whether it may be reprocessed. Such indication shall be included in the technical documentation referred to in Annex II.

Or. en

Amendment 362

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. An indication that a device is for single use shall be based on the manufacturer's risk management documentation, where characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used shall be identified.

Or. en

Amendment 363

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. It shall be the responsibility of the manufacturer to indicate whether a device is intended for single use or whether it may be reprocessed. That indication shall be based on the design, construction, materials and chemical, physical and biological properties of the device, on the applicable clinical and market requirements and user needs, while having regard to the known characteristics and technical factors liable to pose a risk should the device be re-used. Those characteristics and technical factors shall be documented in the manufacturer's risk management documentation. The indication shall be included in the technical documentation referred to in Annex II.

Or. en

Amendment 364

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. In principle, a device shall be for single-use. It shall be the responsibility of the manufacturer to indicate whether a device is intended for single-use or whether it may be reprocessed. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication that the device is not for single use shall be part of the technical documentation referred to in Annex II.

Or. fr

Amendment 365

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose following appropriate reprocessing. The technical documentation referred to in Annex II shall specify whether the device is intended for single use or is suitable for reprocessing for reuse and shall provide the grounds for that designation, including why safe reprocessing cannot be ensured.

Or. en

Amendment 366

Ondřej Dostál

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. It shall be the responsibility of the manufacturer to indicate whether a device is intended for single-use or whether it may be reprocessed. This indication shall be based on the design, construction, materials and chemical, physical and biological properties of the device and shall be included in the technical documentation referred to in Annex II.

Or. en

Justification

Amendment 38, which requires the manufacturer to include a reasoned justification in the technical documentation explaining why safe reprocessing cannot be ensured, imposes an excessive burden.

Amendment 367

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. It shall be the responsibility of the manufacturer to indicate whether a device is intended for single-use or whether it may be reprocessed. This indication shall be based on the design, construction, materials and chemical, physical and biological properties of the device and shall be included in the technical documentation referred to in Annex II.

Or. en

Amendment 368

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. It shall be the responsibility of the manufacturer to indicate whether a device is intended for single-use or whether it may be reprocessed. This indication shall be based on the design, construction, materials and chemical, physical and biological properties of the device and shall be included in the technical documentation referred to in Annex II.

Or. en

Amendment 369

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.1. A single-use device shall only be reprocessed or fully refurbished where the natural or legal person that carries out the reprocessing or full refurbishing can ensure safety and performance of the device with specific knowledge of the single use device in light of the design, construction, material composition, chemical, physical and biological properties of the device, in accordance with its intended purpose after appropriate reprocessing.

Or. en

Justification

The amendment ensures single-use designation remains with the manufacturer, who alone holds the technical knowledge to assess reprocessing risks. Requiring manufacturers to justify non-reprocessability is disproportionate and open-ended.

Amendment 370

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 2

Text proposed by the CommissionAmendment
2. If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).deleted

Or. en

Amendment 371

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 2

Text proposed by the CommissionAmendment
2. If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).2. If the device is not intended for single-use but is nevertheless reusable, that information shall be included on the label and the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).

Or. it

Justification

In the interests of providing transparent information for users, the product label should clearly state that the device can be reprocessed.

Amendment 372

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 2

Text proposed by the CommissionAmendment
2. If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).2. If the device is not intended for single-use, but is reusable, that shall be indicated on the label, and the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).

Or. en

Amendment 373

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 2

Text proposed by the CommissionAmendment
2. If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).2. Where a device is not intended for single use, the manufacturer shall provide, in the instructions for use in accordance with Annex I, Section 23.4, point (n), information on the appropriate reprocessing process necessary to enable the safe reuse of the device.

Or. en