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opinion parliamentary committee draft, 16 June 2026

On the proposal for a regulation of the European Parliament and of the Council 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 IMCO-PA-789887 · (COM(2025)1023 – C100360/2025 – 2025/0404(COD))

Committee on the Internal Market and Consumer Protection · Rapporteur: Maria Guzenina

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The Commission’s proposal to change Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) rightly seeks to make the framework more efficient and less burdensome, particularly for SMEs, specialised manufacturers and producers of orphan and breakthrough devices. The rapporteur’s draft Opinion welcomes this approach while safeguarding the continued high level of patient and consumer safety. The draft Opinion combines reduced administrative burdens with strong accountability, transparency and oversight.

On certificate validity, the rapporteur proposes on first certification an initial validity period of up to five years, followed by a re-assessment. Where the evidence confirms continued safety and performance, certificates may then be granted unlimited validity. This provides greater certainty for manufacturers while preserving scrutiny where post-market evidence or technological developments raise concerns. Appropriate sampling and testing requirements are also maintained.

The rapporteur’s draft Opinion also retains the requirement for unannounced audits to be conducted at least once every five years as an essential safeguard for verifying safety of medical and in vitro diagnostic medical devices.

The rapporteur also expresses strong reservations regarding the proposal to move the MDR and IVDR from section A to B of Annex I of the AI Act. Rather than providing clarity, this shift risks severely fragmenting Europe’s AI legislation and undermining the horizontal nature of the AI Act. Creating a separate and siloed AI regime for medical devices would invite regulatory duplication, legal uncertainty, and serious interpretation issues for both authorities and manufacturers.

The rapporteur considers that notified body fees should not become a barrier to market access, particularly for smaller manufacturers and producers of orphan and breakthrough devices. Given the public-interest role performed by notified bodies, the draft Opinion introduces proportionate fee reductions for micro and small enterprises and for orphan and breakthrough devices, while safeguarding the viability of notified bodies that are themselves often micro-enterprises.

Transparency is strengthened by requiring safety summaries to be understandable to patients and publicly available on Eudamed.

In conclusion, the rapporteur’s overall objective is a clear and predictable framework that upholds the high level of patient and consumer safety while supporting innovation and maintaining a diverse European market for medical and in vitro diagnostic medical devices.

AMENDMENTS

The Committee on the Internal Market and Consumer Protection submits the following to the Committee on Public Health, as the committee responsible:

Amendment 1

Proposal for a regulation

Recital 14

Read the rest (673 paragraphs)
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 2

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 additionally in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users.

Or. en

Amendment 3

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, 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.

Or. en

Amendment 4

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 5

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 6

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 reductions.
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 7

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 re-assess whether the certificate can be renewed. Such re-assessments safeguard patient safety, but may create administrative burden, uncertainty and unnecessary costs. To make the system more proportionate, the maximum validity period of certificates issued by notified bodies should be removed after positive re-assessment, 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. Manufacturers could renew such time-limited certificates following by a more targeted assessment process.

Or. en

Amendment 8

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 5 – paragraph 5 – subparagraph 1 – 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 when authorised by the competent authority in the duly justified interest of public health, patient safety or patient health, or to respond to a public health emergency at Union level recognised in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council;

Or. en

Amendment 9

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 5 – paragraph 5 – subparagraph 4 a (new)

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 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 5 years.

Or. en

Amendment 10

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. en

Amendment 11

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.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 12

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. The Member State that issues such an order shall, without undue delay, communicate it through Eudamed.

Or. en

Amendment 13

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point c

Regulation (EU) 2017/745

Article 10 – paragragh 10

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

Or. en

Amendment 14

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point d

Regulation (EU) 2017/745

Article 10 – paragraph 11 – subparagraph 2

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, Member States shall consider accepting additionally 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 15

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 16

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 10 – paragraph 14 – subparagraph 3

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

Or. en

Amendment 17

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 10 – paragraph 14 – subparagraph 4

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

Or. en

Amendment 18

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:
'16. 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 19

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 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 20

Proposal for a regulation

Article 1 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/745

Article 10a – paragraph 6 a (new)

Text proposed by the CommissionAmendment
6a. Based on the reporting and information exchange referred to in paragraphs 1, 2, 3 and 4, Member States shall publish and regularly update, in a publicly available and user-friendly database, information on actual and expected interruptions or discontinuations of the supply of devices assessed by their competent authority';

Or. en

Amendment 21

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.;deleted

Or. en

Amendment 22

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 permanently and continuously at their disposal.
****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).’;****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 23

Proposal for a regulation

Article 1 – paragraph 1 – point 13 – point d

Regulation (EU) 2017/745Article 15 – paragraph 6

Text proposed by the CommissionAmendment
(d) paragraph 6 is replaced by the following:deleted
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.;

Or. en

Amendment 24

Proposal for a regulation

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

Regulation 2017/745

Article 16 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the CommissionAmendment
(aa) in paragraph 3, the following subparagraph is inserted after the first subparagraph:
In case of a change of pack size, the distributor or importer shall in addition indicate the original package quantity and the new package quantity. By way of derogation from Annex VI, Part C, an importer or distributor who changes the quantity of devices contained within an outer packaging in accordance with paragraph 2(b) shall not be required to assign or obtain a new UDI-DI for the repackaged device. The importer or distributor shall reproduce on the repackaged outer packaging the UDI originally assigned by the manufacturer to the packaging from which the devices were taken.

Or. en

(32017R0745)

Amendment 25

Proposal for a regulation

Article 1 – paragraph 1 – point 16 a (new)

Regulation (EU) 2017/745

Article 19 – paragraph 1

Present textAmendment
(16a) In article 19, paragraph 1 is replaced by the following:
1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.‘1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available. The manufacturer shall make the EU declaration of conformity available through Eudamed. The EU declaration of conformity shall be accessible to economic operators for the fulfilment of their obligations under this Regulation.’

Or. en

(32017R0745)

Amendment 26

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EU) 2017/745

Article 29 – paragraph 3

Text proposed by the CommissionAmendment
3. For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in Article 52(4), second and third subparagraphs, the notified body shall confirm in Eudamed that the information referred to in Part B of Annex VI is correct.;3. For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in Article 52(4), second and third subparagraphs, the notified body shall confirm in Eudamed that the information referred to in Part B points 2, 5-9, 19, 21, 22 and 23 of Annex VI is correct.;

Or. en

Amendment 27

Proposal for a regulation

Article 1 – paragraph 1 – point 24 – point a

Regulation (EU) 2017/745

Article 32 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
The summary of safety and clinical performance shall be written in a way that is clear to the intended user and shall be made available to the public via Eudamed.The summary of safety and clinical performance shall be written in a way that is clear to the intended user and to the patient and shall be made available to the public via Eudamed.

Or. en

Amendment 28

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 2

Text proposed by the CommissionAmendment
2. Notified bodies shall apply at least a 50 % fee reduction for manufacturers that are micro enterprises within the meaning of Recommendation 2003/361/EC and at least a 25 % fee reduction for small enterprises within the meaning of that Recommendation. They shall apply at least a 50 % fee reduction for manufacturers that apply for conformity assessment of an orphan device referred to in Article 52a(3). Notified bodies shall provide manufacturers that are micro or small enterprises within the meaning of Recommendation 2003/361/EC the possibility to defer the payment of fees until the relevant conformity assessment activity is finalised.2. Except for notified bodies that are micro-enterprises within the meaning of Recommendation 2003/361/EC, they shall apply up to at least a 50 % annual fee reduction for manufacturers that are micro enterprises within the meaning of Recommendation 2003/361/EC proportionate to their annual turnover and up to a 25 % annual fee reduction for small enterprises within the meaning of that Recommendation, proportionate to their annual turnover. They shall apply up to a 50 % fee reduction for manufacturers that apply for conformity assessment of an orphan device referred to in Article 52a(3).

Or. en

Amendment 29

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 3 – introductory part

Text proposed by the CommissionAmendment
3. The Commission, in consultation with the MDCG, may adopt implementing acts to specify the structure and level of the fees referred to in paragraph 1, taking into account the need to:3. The Commission, in consultation with the MDCG, may adopt delegated acts to specify the structure and level of the fees referred to in paragraph 1, taking into account the need to:

Or. en

Amendment 30

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 3 – point a

Text proposed by the CommissionAmendment
(a) establish and maintain high standards of quality and safety of devices;(a) establish and maintain high standards of quality and safety of persons and devices;

Or. en

Amendment 31

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 5

Text proposed by the CommissionAmendment
5. Notified bodies shall deal with any request for conformity assessment activities from a manufacturer and, within 15 days of receipt of the request, inform the manufacturer accordingly.5. Notified bodies shall deal with any request for conformity assessment activities from a manufacturer and, within 20 days of receipt of the request, inform the manufacturer accordingly.

Or. en

Amendment 32

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 6

Text proposed by the CommissionAmendment
6. When duly justified in the interest of public health or patient health or safety, the authority responsible for notified bodies may instruct a notified body to accept a manufacturer’s request for conformity assessment activities falling within that notified body’s scope of designation.;6. When duly justified in the interest of public health or patient health or safety and without prejudice to the available administrative and judicial remedies for notified bodies under EU and Member State law, the authority responsible for notified bodies may instruct a notified body to accept a manufacturer’s request for conformity assessment activities falling within that notified body’s scope of designation.;

Or. en

Amendment 33

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point a

Regulation (EU) 2017/745

Article 52 – paragraph 3 – subparagraph 2

Text proposed by the CommissionAmendment
By way of derogation from the first subparagraph, class III devices that are well-established technology devices shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of one representative device per generic device group.;deleted

Or. en

Amendment 34

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point b

Regulation (EU) 2017/745

Article 52 – paragraph 4 – subparagraph 1

Text proposed by the CommissionAmendment
Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of one representative device per generic device group or, in the case of non-implantable class IIb devices that are well-established technology devices, one representative device per each category of devices.Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of at least one representative device per generic device group or, in the case of non-implantable class IIb devices that are well-established technology devices, at least one representative device per each category of devices.

Or. en

Amendment 35

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point d

Regulation (EU) 2017/745

Article 52 – paragraph 6 – subparagraph 1

Text proposed by the CommissionAmendment
Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of one representative device for each category of devices.Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of at least one representative device for each category of devices.

Or. en

Amendment 36

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point d

Regulation (EU) 2017/745

Article 52 – paragraph 6 – subparagraph 2

Text proposed by the CommissionAmendment
Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for one representative device for each category of devices.;Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.;

Or. en

Amendment 37

Proposal for a regulation

Article 1 – paragraph 1 – point 46

Regulation (EU) 2017/745

Article 54 – paragraph 4

Text proposed by the CommissionAmendment
4. The notified body shall give utmost consideration to the opinion issued by the expert panel in the framework of the clinical evaluation consultation procedure. Where the notified body has not followed the views and recommendations expressed in that opinion, it shall provide a substantiated justification of the reasons therefore and its final clinical evaluation assessment report to the authority responsible for notified bodies of the Member State in which it is established, to the expert panel that issued the opinion and to the Commission.4. The notified body shall give utmost consideration to the opinion issued by the expert panel in the framework of the clinical evaluation consultation procedure. Where the notified body has not followed the views and recommendations expressed in that opinion, it shall provide a substantiated justification of the reasons therefore and its final clinical evaluation assessment report shall be made publicly available on Eudamed.

Or. en

Amendment 38

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point a

Regulation (EU) 2017/745

Article 56 – paragraph 1

Text proposed by the CommissionAmendment
1. The notified bodies shall issue certificates in accordance with Annexes IX, X and XI in an official Union language and immediately upload them in Eudamed. The minimum content of the certificates shall be as set out in Annex XII.1. The notified bodies shall issue certificates in accordance with Annexes IX, X and XI in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body and immediately upload them in Eudamed. The minimum content of the certificates shall be as set out in Annex XII.

Or. en

Amendment 39

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point a

Regulation (EU) 2017/745

Article 56 – paragraph 2

Text proposed by the CommissionAmendment
2. The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the notified body may extend the validity of a certificate following a re-assessment performed in accordance with Annex VII, Section 4.11. Following a positive re-assessment, the validity of the certificate shall not be limited in time, unless the notified body considers it necessary, on duly justified grounds, to issue a further time-limited certificate not exceeding five years. Any supplement to a certificate shall remain valid for as long as the certificate which it supplements.

Or. en

Amendment 40

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point b

Regulation (EU) 2017/745

Article 56 – paragraph 2a

Text proposed by the CommissionAmendment
2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.;2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews in particular following re-certification, taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device. The European Commission shall, by means of implementing acts, establish detailed rules on the modalities and frequency of periodic reviews.

Or. en

Amendment 41

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 2

Text proposed by the CommissionAmendment
2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that shall clearly identify the requirements of this Regulation referred to in paragraph 1, which, by way of derogation from this Regulation, are temporarily adapted or waived in the regulatory sandbox, a justification that the application of those requirements is considered not appropriate and an explanation as to how potential risks related to the adaptation or waiver are controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that shall clearly identify the requirements of this Regulation referred to in paragraph 1, which, by way of derogation from this Regulation, are temporarily adapted in the regulatory sandbox, a justification that the application of those requirements is considered not appropriate and an explanation as to how potential risks related to the adaptation are controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.

Or. en

Amendment 42

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 3 – point b a (new)

Text proposed by the CommissionAmendment
(ba) is designed and conducted in such a way that the rights, safety, dignity and well-being of subjects participating in research activities are protected and prevail over all other interests.

Or. en

Amendment 43

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 7

Text proposed by the CommissionAmendment
7. The Member State shall inform the Commission and the MDCG about the establishment of a regulatory sandbox and keep them informed about its implementation and outcome.7. The Member State shall inform the Commission and the MDCG about the establishment of a regulatory sandbox, ensure close monitoring throughout its duration, and keep them informed about its implementation and outcome.

Or. en

Amendment 44

Proposal for a regulation

Article 1 – paragraph 1 – point 50 a (new)

Regulation (EU) 2017/745

Article 59 d (new)

Text proposed by the CommissionAmendment
(50a) The following Article 59d is inserted:
Article 59d
Transparency of regulatory sandboxes
Based on the information received from Member States pursuant to Article 59b(7) and on the information shared with the MDCG pursuant to Article 59c (3), the European Commission shall draw up and make publicly available through Eudamed an annual report with a breakdown on the number of sandboxes granted, and detailed information on their implementation and outcomes. The report shall be published together with a lay summary.

Or. en

Justification

Transparency provisions in relation to sandboxes are necessary to ensure accountability and public trust. Lay summaries can help make these frameworks more understandable to non-experts.

Amendment 45

Proposal for a regulation

Article 1 – paragraph 1 – point 65

Regulation (EU) 2017/745

Article 83 – paragraph 4

Text proposed by the CommissionAmendment
If in the course of the post-market surveillance, a need for preventive or corrective action, or both, is identified, the manufacturer shall implement the appropriate measures. The competent authorities concerned may request the manufacturer to inform them when such preventive or corrective action is taken to reduce a risk that may compromise the safety or performance of the device.;deleted

Or. en

Amendment 46

Proposal for a regulation

Article 1 – paragraph 1 – point 67 – point a – point ii

Regulation (EU) 2017/745

Article 86 – paragraph 1– subparagraph 3

Text proposed by the CommissionAmendment
Manufacturers of class IIa devices shall update the PSUR when necessary. The PSURs shall be part of the technical documentation specified in Annex III. ;Manufacturers of class IIa devices shall update the PSUR when necessary, and at least every 3 years. The PSURs shall be part of the technical documentation specified in Annex III. ;

Or. en

Amendment 47

Proposal for a regulation

Article 1 – paragraph 1 – point 68 – point b a (new)

Regulation (EU) 2017/745

Article 87 – paragraph 10 – subparagraph 1 a (new)

Present textAmendment
(ba) in paragraph 10, the following subparagraph is inserted after the first subparagraph:
Member States shall facilitate reporting through the provision of alternative reporting formats in addition to user friendly web-based formats that fulfil the accessibility requirements set out in Directive (EU) 2016/2102.

Or. en

(32017R0745)

Amendment 48

Proposal for a regulation

Article 1 – paragraph 1 – point 96

Regulation (EU) 2017/745

Article 121 – paragraph 1

Text proposed by the CommissionAmendment
No sooner than …[Publications Office, please insert the date five years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council.No sooner than …[Publications Office, please insert the date five years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall, in particular, assess:
(a) the impact of this Regulation on the functioning of the internal market for medical devices and in vitro diagnostic medical devices, including on the free movement of safe and effective devices, the level of harmonisation achieved, any remaining barriers for micro and small companies, and the extent to which harmonisation and the revised rules have translated into consistent patient safety outcomes across Member States;
(b) the cumulative impact of regulatory requirements on micro, small and medium-sized enterprises, including whether simplification measures have meaningfully reduced administrative and compliance burdens, the extent to which SME market exit has led to reduced availability of specialised or niche devices, and whether the regulation has created structural barriers favouring larger economic operators;

Or. en

Amendment 49

Proposal for a regulation

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

Regulation (EU) 2017/746

Article 5 – paragraph 5 – subparagraph 1 – introductory part

Present textAmendment
(-1) the introductory part is replaced by the following :
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:"Devices manufactured and used only within health institutions established in the Union shall comply with the relevant general safety and performance requirements set out in Annex I, but shall be exempt from other requirements of this Regulation, provided that all of the following conditions are met:

Or. en

(32017R0746)

Amendment 50

Proposal for a regulation

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

Regulation (EU) 2017/746

Article 5 – paragraph 5 – subparagraph 1 – 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 when authorised by the competent authority in the duly justified interest of public health, patient safety or patient health, or to prepare or respond to a public health emergency at Union level recognised in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council;

Or. en

Amendment 51

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point i – point 4

Regulation (EU) 2017/746

Article 5– paragraph 5 – subparagraph 1 – point e

Text proposed by the CommissionAmendment
(e) upon request by a competent authority, the health institution provides information on the use of such devices to its competent authority, which shall include the justification referred to in point (a);;(e) upon request by a competent authority, the health institution provides information on the use of such devices and if and how they are shared with other health institutions, to its competent authority, which shall include the justification referred to in point (a);

Or. en

Amendment 52

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/746

Article 5 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission is empowered to adopt delegated acts in accordance with Article 108, 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. en

Amendment 53

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/746

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 54

Proposal for a regulation

Article 2 – paragraph 1 – point 6 – point b

Regulation (EU) 2017/746

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 Article 1(1), point (b), of Directive (EU) 2015/1535, or the provider of the service referred to in 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 Article 1(1), point (b), of Directive (EU) 2015/1535, or the provider of the service referred to in paragraph 2, to cease its activity. The Member State that issues such an order shall, without undue delay, communicate it through Eudamed. ;

Or. en

Amendment 55

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point c

Regulation (EU) 2017/746

Article 10 – paragraph 9

Text proposed by the CommissionAmendment
(c) paragraph 9 is deleted;deleted

Or. en

Amendment 56

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point d – point i

Regulation (EU) 2017/746

Article 10 – paragraph 10 – subparagraph 1

Text proposed by the CommissionAmendment
When determining the official language of the Union in which the information set out in Section 20 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 20 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting additionally 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 57

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point d – point ii

Regulation (EU) 2017/746

Article 10 – paragraph 10 – subparagraph 2

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

Or. en

Amendment 58

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point e

Regulation (EU) 2017/746

Article 10 – paragraph 12

Text proposed by the CommissionAmendment
(e) paragraph 12 is deleted;deleted

Or. en

Amendment 59

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point f

Regulation (EU) 2017/746

Article 10 – paragraph 13 – subparagraphs 3 and 4

Text proposed by the CommissionAmendment
(f) in paragraph 13, the third and fourth subparagraphs are deleted;deleted

Or. en

Amendment 60

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point h

Regulation 2017/746

Article 10 – paragraph 15

Text proposed by the CommissionAmendment
(h) paragraph 15 is deleted;(h) paragraph 15 is replaced by the following;
15. 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 61

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation 2017/746

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 of the European Parliament and of the Council***, 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 of the European Parliament and of the Council***, 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 shall be consulted.
*** 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).’;*** 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 62

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b a (new)

Regulation 2017/746

Article 10a – paragraph 6 a (new)

Text proposed by the CommissionAmendment
(ba) the following paragraph is added:
6a. Based on the reporting and information exchange referred to in paragraphs 1, 2, 3 and 4, Member States shall publish and regularly update, in a publicly available and user-friendly database, information on actual and expected interruptions or discontinuations of the supply of devices assessed by their competent authority.

Or. en

Amendment 63

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point a

Regulation 2017/746

Article 15 – paragraph 1

Text proposed by the CommissionAmendment
(a) paragraph 1 is replaced by the following:deleted
‘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 in vitro diagnostic medical devices.;’

Or. en

Amendment 64

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point b

Regulation 2017/746

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 permanently and continuously at their disposal.
**** 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).’;**** 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 65

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point d

Regulation 2017/746

Article 15 – paragraph 6

Text proposed by the CommissionAmendment
(d) paragraph 6 is replaced by the following:deleted
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 for in vitro diagnostic medical devices in the Union.;

Or. en

Amendment 66

Proposal for a regulation

Article 2 – paragraph 1 – point 14 – point a a (new)

Regulation 2017/746

Article 16 – paragraph 3 – subparagraph 1 a (new)

Present textAmendment
(aa) in paragraph 3, the following subparagraph is inserted after the first subparagraph:
In case of a change of pack size, the distributor or importer shall in addition indicate the original package quantity and the new package quantity. By way of derogation from Annex VI, Part C, an importer or distributor who changes the quantity of devices contained within an outer packaging in accordance with paragraph 2(b) shall not be required to assign or obtain a new UDI-DI for the repackaged device. The importer or distributor shall reproduce on the repackaged outer packaging the UDI originally assigned by the manufacturer to the packaging from which the devices were taken.

Or. en

(32017R0746)

Amendment 67

Proposal for a regulation

Article 2 – paragraph 1 – point 15 – point a

Regulation 2017/746

Article 17 – paragraph 1

Text proposed by the CommissionAmendment
(a) in paragraph 1, the first sentence is replaced by the following:(a) paragraph 1 is replaced by the following:
‘The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered by that declaration.’;1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available. The manufacturer shall make the EU declaration of conformity available through EUDAMED. The EU declaration of conformity shall be accessible to economic operators for the fulfilment of their obligations under this Regulation.

Or. en

This amendment seeks to replace a provision within the existing act – Article 17(1) – that was not set out in full in the Commission proposal.

Amendment 68

Proposal for a regulation

Article 2 – paragraph 1 – point 19

Regulation 2017/746

Article 26 – paragraph 2

Text proposed by the CommissionAmendment
2. For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), Article 48(7), second subparagraph, Article 48(8), and Article 48(9), second subparagraph, the notified body shall confirm in Eudamed that the information referred to in Part B of Annex VI is correct.;2. For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), Article 48(7), second subparagraph, Article 48(8), and Article 48(9), second subparagraph, the notified body shall confirm in Eudamed that the information referred to in Part B points 2, 5–7, 17, 19, 20 and 21 of Annex VI is correct.;

Or. en

Amendment 69

Proposal for a regulation

Article 2 – paragraph 1 – point 22 – point a

Regulation 2017/746

Article 29 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
The summary of safety and performance shall be written in a way that is clear to the intended user.The summary of safety and performance shall be written in a way that is clear to the intended user and to the patient.

Or. en

Amendment 70

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point a

Regulation 2017/746

Article 51 – paragraph 1

Text proposed by the CommissionAmendment
1. The notified bodies shall issue certificates in accordance with Annexes IX, X and XI in an official language of the Union and immediately upload them in Eudamed. The minimum content of the certificates shall be as set out in Annex XII.1. The notified bodies shall issue certificates in accordance with Annexes IX, X and XI in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body and immediately upload them in Eudamed. The minimum content of the certificates shall be as set out in Annex XII.

Or. en

Amendment 71

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point a

Regulation 2017/746

Article 51 – paragraph 2

Text proposed by the CommissionAmendment
2. The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.;2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the notified body may extend the validity of a certificate following a re-assessment performed in accordance with Annex VII, Section 4.11. Following a positive re-assessment, the certificate shall not be limited in time, unless the notified body considers it necessary, on duly justified grounds, to issue a further time-limited certificate not exceeding five years. Any supplement to a certificate shall remain valid for as long as the certificate which it supplements.;

Or. en

Amendment 72

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point b

Regulation 2017/746

Article 51 – paragraph 2a

Text proposed by the CommissionAmendment
2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.;2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews in particular following re-certification, taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device. The European Commission shall, by means of implementing acts, establish detailed rules on the modalities and frequency of periodic reviews.;

Or. en

Amendment 73

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation 2017/746

Article 54b – paragraph 2

Text proposed by the CommissionAmendment
2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that clearly identify the requirements of this Regulation referred to in paragraph 1, which are temporarily adapted or waived in the regulatory sandbox, a justification that the application of those requirements is not considered to be appropriate and an explanation as to how potential risks related to the adaptation or waiver are to be controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that clearly identify the requirements of this Regulation referred to in paragraph 1, which are temporarily adapted in the regulatory sandbox, a justification that the application of those requirements is not considered to be appropriate and an explanation as to how potential risks related to the adaptation are to be controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.

Or. en

Amendment 74

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation 2017/746

Article 54b – paragraph 3 – point b a (new)

Text proposed by the CommissionAmendment
(ba) is designed and conducted in such a way that the rights, safety, dignity and well-being of subjects participating in research activities are protected and take precedence over all other interests.

Or. en

Amendment 75

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation 2017/746

Article 54b – paragraph 7

Text proposed by the CommissionAmendment
7. The Member State shall inform the Commission and the MDCG about the establishment of a regulatory sandbox and keep them informed about its implementation and outcome.7. The Member State shall inform the Commission and the MDCG about the establishment of a regulatory sandbox, ensure close monitoring throughout its duration, and keep them informed about its implementation and outcome.

Or. en

Amendment 76

Proposal for a regulation

Article 2 – paragraph 1 – point 36 a (new)

Regulation 2017/746

Article 54 d (new)

Text proposed by the CommissionAmendment
(36a) the following Article 54d is inserted :
Article 54d Transparency of regulatory sandboxes
Based on the information received from Member States pursuant to Article 54b (7) and on the information shared with the MDCG pursuant to Article 54c (3), the European Commission shall draw up and make publicly available through Eudamed an annual report with a breakdown on the number of sandboxes granted, and detailed information on their implementation and outcomes. The report shall be published together with a lay summary.

Or. en

Amendment 77

Proposal for a regulation

Article 2 – paragraph 1 – point 51

Regulation 2017/746

Article 78 – paragraph 4

Text proposed by the CommissionAmendment
(51) in Article 78(4), the first sentence is replaced by the following:deleted
‘If, in the course of the post-market surveillance, a need for preventive or corrective action, or both, is identified, the manufacturer shall implement the appropriate measures. The competent authorities concerned may request the manufacturer to inform them when such action is taken to reduce a risk that may compromise the safety or performance of the device.;’

Or. en

Amendment 78

Proposal for a regulation

Article 2 – paragraph 1 – point 54 - point b a (new)

Regulation 2017/746

Article 82 – paragraph 10 – subparagraph 1 a (new)

Present textAmendment
(ba) in paragraph 10, the following subparagraph is inserted after the first subparagraph:
The Member States shall facilitate reporting through the provision of alternative reporting formats in addition to user friendly web-based formats that fulfil the accessibility requirements set out in Directive (EU) 2016/2102.

Or. en

(32017R0746)

Amendment 79

Proposal for a regulation

Article 2 – paragraph 1 – point 79

Regulation 2017/746

Article 111

Text proposed by the CommissionAmendment
(79) Article 111 is amended as follows:(79) Article 111 is replaced by the following:
(a) in the first sentence, the date
Article 111
Evaluation
‘27 May 2027’ is replaced by the date …‘[OP, please insert the date = five years after the date of entry into force of this Regulation]’;No sooner than …[Publications Office, please insert the date five years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall, in particular, assess:
(a) the impact of this Regulation on the functioning of the internal market for medical devices and in vitro diagnostic medical devices, including on the free movement of safe and effective devices, the level of harmonisation achieved, any remaining barriers for micro and small companies, and the extent to which harmonisation and the revised rules have translated into consistent patient safety outcomes across Member States;
(b) the cumulative impact of regulatory requirements on micro, small and medium-sized enterprises, including whether simplification measures have meaningfully reduced administrative and compliance burdens, the extent to which SME market exit has led to reduced availability of specialised or niche devices, and whether the regulation has created structural barriers favouring larger economic operators;
Member States and notified bodies shall provide the Commission with the information necessary for the preparation of that report.
(b) the second sentence is deleted;

Or. en

This amendment seeks to replace a provision within the existing act – Article 111 – that was not set out in full in the Commission proposal.

Amendment 80

Proposal for a regulation

Article 4

Regulation (EU) 2024/1689

Article 4

Text proposed by the CommissionAmendment
Article 4deleted
Amendments to Regulation (EU) 2024/1689
Annex I to Regulation (EU) 2024/1689 is amended as follows:
(1) in Section A, points 11 and 12 are deleted;
(2) in Section B, the following points are added:
‘21. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).’.

Or. en

Amendment 81

Proposal for a regulation

Annex I – paragraph 1 – point 4 – point b – point i a (new)

Regulation 2017/745

Annex VI – Part C – Section 3.9

Present textAmendment
(ia) Section 3.9 is replaced by the following:
3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:"3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a)name or trade name,(a) name or trade name,
(b)device version or model,(b) device version or model,
(c)labelled as single use,(c) labelled as single use,
(d)packaged sterile,(d) packaged sterile,
(e)need for sterilization before use,(e) need for sterilization before use,
(f)quantity of devices provided in a package,(f) quantity of devices provided in a package, except where the change is performed by an importer or distributor in accordance with Article 16(2)(b)
(g)critical warnings or contra-indications: e.g. containing latex or DEHP.(g) critical warnings or contra-indications: e.g. containing latex or DEHP.

Or. en

(32017R0745)

Amendment 82

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point v a (new)

Regulation 2017/745

Annex VII – Section 4.6. – paragraph 3a (new)

Text proposed by the CommissionAmendment
(va) in Section 4.6. the following third paragraph is inserted:
3a. The performance evaluation assessment report shall also be published on Eudamed at time of publication of the conformity assessment certificate, together with a layperson’s summary.

Or. en

Amendment 83

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point y a (new)

Regulation 2017/745

Annex VII – Section 4.10a (new)

Text proposed by the CommissionAmendment
(ya) the following section 4.10a is inserted:
4.10a. Re-certification
The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur once, in accordance with Article 56.
The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
(a) all changes to the originally approved device, including changes not yet notified,
(b) experience gained from post-market surveillance,
(c) experience from risk management,
(d) experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,
(e) experience from reviews of the performance evaluation, including the results of any performance studies and PMPF,
(f) changes to the requirements, to components of the device or to the scientific or regulatory environment,
(g) changes to applied or new harmonised standards, CS or equivalent documents, and
(h) changes in medical, scientific and technical knowledge, such as:
- new treatments,
- changes in test methods,
- new scientific findings on materials and components, including findings on their biocompatibility,
- experience from studies on comparable devices,
- data from registers and registries,
- experience from performance studies with comparable devices.
The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMPF activities undertaken since the previous certification, including appropriate updates to manufacturers' performance evaluation reports.
For the decision on re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps taken for certification such as application and application review.

Or. en

Amendment 84

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point z

Regulation 2017/745

Annex VII – Section 4.11 – paragraph 2

Text proposed by the CommissionAmendment
Those procedures shall require the manufacturer in question to submit at predefined intervals a summary of changes and of relevant data gathered by the manufacturer’s post-market surveillance system. The notified body shall assess such information and shall pay particular attention to clinical data from post-market surveillance and PMCF activities undertaken since the previous certification or periodic review, including appropriate updates to manufacturers' clinical evaluation reports, without repeating assessments already conducted.Those procedures shall require the manufacturer in question to submit at predefined intervals, in particular following re-certification, a summary of changes and of relevant data gathered by the manufacturer’s post-market surveillance system. The notified body shall assess such information and shall pay particular attention to clinical data from post-market surveillance and PMCF activities undertaken since the previous certification or periodic review, including appropriate updates to manufacturers' clinical evaluation reports, without repeating assessments already conducted.

Or. en

Amendment 85

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point z

Regulation 2017/745

Annex VII – Section 4.11 – paragraph 3

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place relating to the extension of the period of validity of a certificate in cases where it has exceptionally limited the period of validity. Those procedures shall require the manufacturer to submit prior to the expiry of the certificate the data or documentation specified by the notified body to enable it to decide about the extension of the period of validity of the certificate.;The notified body shall have documented procedures in place relating to the extension of the period of validity of a certificate in cases where it has exceptionally limited the period of validity following re-certification. Those procedures shall require the manufacturer to submit prior to the expiry of the certificate the data or documentation specified by the notified body to enable it to decide about the extension of the period of validity of the certificate.;

Or. en

Amendment 86

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point d – point i

Regulation 2017/745

Annex IX – Section 3.4 – paragraph 1

Text proposed by the CommissionAmendment
The notified body shall perform short-notice or unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors when justified based on concerns related to post-market surveillance or vigilance data or at the request of a competent authority. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.;The notified body shall perform audits at least once every five years, at short notice or unannounced, on the site of the manufacturer and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors. On justified grounds, the short notice or unannounced audit may be conducted remotely instead of on-site. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment. The notified body shall establish a plan for such short notice or unannounced on-site audits but shall not disclose it to the manufacturer.;

Or. en

Amendment 87

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point e

Regulation (EU) 2017/745

Annex IX – Section 3.5 – paragraph 1

Text proposed by the CommissionAmendment
In the case of class IIa and class IIb devices, and of class III devices that are well-established technology devices, during the surveillance assessment the notified body may include a ‘for-cause’ assessment of the technical documentation of representative devices where the notified body has identified potential concerns on the basis of post-market surveillance data or other duly justified grounds.In the case of class IIa and class IIb devices, and of class III devices that are well-established technology devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the second paragraph of Section 2.3.

Or. en

Amendment 88

Proposal for a regulation

Annex II – paragraph 1 – point 4 – point b – point i a (new)

Regulation 2017/746

Annex VI – Part C – Section 3.9

Present textAmendment
(ia) Section 3.9 is replaced by the following:
3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the following UDI database data elements shall require a new UDI-DI:"3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a)Name or trade name,(a)Name or trade name,
(b)device version or model,(b)device version or model,
(c)labelled as single use,(c)labelled as single use,
(d)packaged sterile,(d)packaged sterile,
(e)need for sterilization before use,(e)need for sterilization before use,
(f)quantity of devices provided in a package,(f)quantity of devices provided in a package, except where the change is performed by an importer or distributor in accordance with Article 16(2)(b)
(g)critical warnings or contra-indications.(g)critical warnings or contra-indications.

Or. en

(32017R0746)

Amendment 89

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point ua (new)

Regulation 2017/746

Annex VII – Section 4.6. – paragraph 3 a (new)

Text proposed by the CommissionAmendment
(ua) in Section 4.6. the following third paragraph is inserted:
The performance evaluation assessment report shall also be published on Eudamed at time of publication of the conformity assessment certificate, together with a layperson’s summary.

Or. en

Amendment 90

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point x a (new)

Regulation 2017/746

Annex VII – Section 4.10a (new)

Text proposed by the CommissionAmendment
(xa) the following section 4.10a is inserted:
4.10a. Re-certification
The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur once, in accordance with Article 51.
The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
(a) all changes to the originally approved device, including changes not yet notified,
(b) experience gained from post-market surveillance,
(c) experience from risk management,
(d) experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,
(e) experience from reviews of the performance evaluation, including the results of any performance studies and PMPF,
(f) changes to the requirements, to components of the device or to the scientific or regulatory environment,
(g) changes to applied or new harmonised standards, CS or equivalent documents, and
(h) changes in medical, scientific and technical knowledge, such as:
- new treatments,
- changes in test methods,
- new scientific findings on materials and components, including findings on their biocompatibility,
- experience from studies on comparable devices,
- data from registers and registries,
- experience from performance studies with comparable devices.
The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMPF activities undertaken since the previous certification, including appropriate updates to manufacturers' performance evaluation reports.
For the decision on re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps taken for certification such as application and application review.

Or. en

Amendment 91

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point y

Regulation 2017/746

Annex VII – Section 4.11 – title

Text proposed by the CommissionAmendment
Periodic reviews and extension of a certificate’s period of validity4.11. Periodic reviews and extension of a certificate’s period of validity

Or. en

Amendment 92

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point y

Regulation 2017/746

Annex VII – Section 4.11 – subparagraph 2

Text proposed by the CommissionAmendment
Those procedures shall require the manufacturer in question to submit at predefined intervals a summary of changes and of relevant data gathered by the manufacturer’s post-market surveillance system. The notified body shall assess such information and shall pay particular attention to clinical evidence gained from post-market surveillance and PMPF activities undertaken since the previous certification or periodic review, including appropriate updates to manufacturers' performance evaluation reports, without repeating assessments already conducted.Those procedures shall require the manufacturer in question to submit at predefined intervals, in particular following re-certification, a summary of changes and of relevant data gathered by the manufacturer’s post-market surveillance system. The notified body shall assess such information and shall pay particular attention to clinical evidence gained from post-market surveillance and PMPF activities undertaken since the previous certification or periodic review, including appropriate updates to manufacturers' performance evaluation reports, without repeating assessments already conducted.

Or. en

Amendment 93

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point y

Regulation 2017/746

Annex VII – Section 4.11 – subparagraph 3

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place relating to the extension of the period of validity of a certificate in cases where it has exceptionally limited the period of validity. Those procedures shall require the manufacturer to submit prior to the expiry of the certificate the data or documentation specified by the notified body to enable it to decide about the extension of the period of validity of the certificate.;The notified body shall have documented procedures in place relating to the extension of the period of validity of a certificate in cases where it has exceptionally limited the period of validity following re-certification. Those procedures shall require the manufacturer to submit prior to the expiry of the certificate the data or documentation specified by the notified body to enable it to decide about the extension of the period of validity of the certificate.;

Or. en

Amendment 94

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point a

Regulation 2017/746

Annex IX – Section 2.3 – paragraph 3 – indent 1

Text proposed by the CommissionAmendment
– for class B devices, one device;– for class B devices, at least one device;

Or. en

Amendment 95

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point a

Regulation 2017/746

Annex IX – Section 2.3 – paragraph 3 – indent 1

Text proposed by the CommissionAmendment
– for class C devices, one device per generic device group.– for class C devices, at least one device per generic device group.

Or. en

Amendment 96

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point d – point i

Regulation 2017/746

Annex IX – Section 3.4 – paragraph 1

Text proposed by the CommissionAmendment
3.4. The notified body shall perform audits, at short notice or unannounced, on the site of the manufacturer and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors, when justified based on concerns related to post-market surveillance or vigilance data or at the request of a competent authority. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.;3.4. The notified body shall perform audits at least once every five years, at short notice or unannounced, on the site of the manufacturer and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors. On justified grounds, the short notice or unannounced audit may be conducted remotely instead of on-site. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment. The notified body shall establish a plan for such short notice or unannounced on-site audits but shall not disclose it to the manufacturer.;

Or. en

Amendment 97

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point e

Regulation 2017/746

Annex IX – section 3.5

Text proposed by the CommissionAmendment
3.5. In the case of class B and class C devices, during the surveillance assessment the notified body may include a ‘for-cause’ assessment of the technical documentation of representative devices where the notified body has identified potential concerns on the basis of post-market surveillance data or other duly justified grounds.;3.5. In the case of class C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the third paragraph of Section 2.3.
In the case of class B, during the surveillance assessment the notified body may include a ‘for-cause’ assessment of the technical documentation of representative devices where the notified body has identified potential concerns on the basis of post-market surveillance data or other duly justified grounds.;

Or. en

Annex: declaration of input 4 paragraphs

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for opinion declares that she included in her draft opinion input on matters pertaining to the subject of the file that she received, in the preparation of the draft opinion, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:

1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register
Affordable Medicines Europe
Alber & Geiger
Becton Dickinson
BioMed Alliance
Bureau Européen des Unions de Consommateurs (BEUC)
European Business Summit
European Patients Forum
European Social Insurance Platform (ESIP)
HealthTech Finland
Helsingin ja Uudenmaan sairaanhoitopiiri (HUS)
Investor AB & Mölnlycke
MedTech Europe
ResMed
Roche Diagnostics
Sailab - MedTech Finland
SGS Fimko Ltd
Standing Committee of European Doctors (CPME)
TÜV Association
UL Solutions
2. Representatives of public authorities of third countries, including their diplomatic missions and embassies
None

The list above is drawn up under the exclusive responsibility of the rapporteur for opinion.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur for opinion declares that she has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.