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EU Parl Watch

amendment list, 28 July 2026

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

Document SANT-AM-791890 · (COM(2025)1023 – 2025/0404(COD))

Committee on Public Health

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Text 2,075 paragraphs

Amendment 374

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 2

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

Or. en

Justification

The amendment ensures single-use designation remains with the manufacturer, who alone holds the technical knowledge to assess reprocessing risks. Requiring manufacturers to justify non-reprocessability is disproportionate and open-ended. Where reprocessing occurs, the reprocessor assumes full liability. Direct part marking ensures traceability and correct liability allocation when labels are removed during clinical use.

Amendment 375

Kateřina Konečná

Read the rest (2,063 paragraphs)

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 2a (new)

Text proposed by the CommissionAmendment
2a. By way of derogation from paragraph 1, Member States may decide to allow reprocessing within a health institution of devices marked as single-use by a manufacturer, provided that they ensure that the safety and performance of the reprocessed device is equivalent to that of the original device.

Or. en

Amendment 376

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.deleted

Or. en

Justification

Full refurbishing of single-use devices creates significant safety, liability and traceability risks. Manufacturers intentionally design single-use devices to prevent reuse — permitting full refurbishment undermines this safety rationale. The liability shift to the refurbisher does not adequately compensate for the risks posed to patients, particularly where design and material knowledge remains exclusively with the original manufacturer.

Amendment 377

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

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person carrying out the full refurbishing shall be considered the manufacturer of the fully refurbished device and shall fulfil the obligations incumbent on manufacturers under this Regulation, including those relating to labelling and traceability in accordance with Chapter III.
Manufacturers carrying out full refurbishing shall demonstrate, through validated technical documentation, that the full refurbishing process does not compromise the safety or performance of the device. Information that a device has undergone full refurbishing, together with the information necessary to ensure its traceability in relation to safe use, shall be included in the labelling of the device and provided to the end user. Article 5(5) shall not apply to fully refurbished devices. A manufacturer shall determine that a device is intended for single use only on the basis of documented technical, safety and performance considerations. Those considerations shall be set out in the technical documentation referred to in Annex II and shall be sufficiently detailed to ensure the uniform application of this Regulation.

Or. en

Amendment 378

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device and must fulfil the obligations incumbent on manufacturers laid down in this Regulation, which also include obligations relating to the labelling and traceability of the fully refurbished device in accordance with Chapter III of this Regulation.
Indication of the fully refurbished state of a device and its traceability in relation to safe use shall be added to the product and delivered to the end user.

Or. en

Amendment 379

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device and must fulfil the obligations incumbent on manufacturers laid down in this Regulation, which also include obligations relating to the labelling and traceability of the refurbished device in accordance with Chapter III of this Regulation. Indication of the refurbished state of a device and its traceability in relation to safe use shall be added to the product and delivered to the end user.

Or. en

Justification

Introducing complete refurbishment calls for a clear distribution of regulatory duties. When a natural or legal person carries out complete refurbishment and is regarded as the manufacturer of the refurbished device, that person should expressly take on all relevant manufacturer responsibilities under the Regulation, including those concerning labelling, traceability, post-market surveillance and vigilance. This provision should apply only where complete refurbishment can be performed safely, and it should ensure that both the refurbished status of the device and its traceability are clearly made known to the end user.

Amendment 380

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device and must fulfil the obligations incumbent on manufacturers laid down in this Regulation, which also include obligations relating to the labelling and traceability of the refurbished device in accordance with Chapter III of this Regulation. Indication of the refurbished state of a device and its traceability in relation to safe use shall be added to the product and delivered to the end user.

Or. en

Amendment 381

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. The natural or legal person that carries out the full refurbishment of a device shall be considered to be the manufacturer of the fully refurbished device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, including the obligations relating to the traceability of the fully refurbished device in accordance with Chapter III. The natural or legal person that carries out the full refurbishment of a device shall inform the manufacturer and the competent authority of the Member State in which they intend to make the device available.

Or. en

Amendment 382

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices that cannot be further reprocessed, or devices that do not indicate whether they are single-use or reprocessable, may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.

Or. it

Justification

The text proposed by the Commission rightly provides that a single-use device, or a device that can no longer be reprocessed, can only be fully refurbished. However, this category of devices should also include devices that do not clearly indicate whether they can be reused. The aim is to provide a higher level of health and safety protection for their users.

Amendment 383

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices that cannot be further reprocessed or devices that do not specify if they are single-use or not, may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.

Or. en

Amendment 384

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

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3

Text proposed by the CommissionAmendment
3. Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.3. Single-use devices and devices may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.

Or. fr

Amendment 385

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3a (new)

Text proposed by the CommissionAmendment
3a. The fact that a device has been fully refurbished, together with the identity of the person responsible for the reprocessing or full refurbishment and the information necessary to ensure the traceability and safe use of the device, shall be clearly indicated on the device, its packaging or in the accompanying information, as appropriate. The device, its packaging and the accompanying information shall not bear any reference to the original manufacturer or the original trade mark.

Or. en

Amendment 386

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 3b (new)

Text proposed by the CommissionAmendment
3b. Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information concerning the reprocessed devices with which patients are treated.

Or. en

Amendment 387

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.’;deleted

Or. fr

Amendment 388

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.;deleted

Or. en

Amendment 389

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.;4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.;
The manufacturer of the reprocessed or full refurbished single-use device shall be considered as the new legal manufacturer and indicate reprocessing or full refurbishment through direct part marking on the device along with proper labeling ensuring full traceability with a specific route in the vigilance system in order to distinguish incidents with original single-use devices from the reprocessed single-use devices, enabling the correct involvement of the responsible legal manufacturer.

Or. en

Justification

Direct part marking and a dedicated vigilance route are essential because labels are routinely removed during clinical use, making reprocessed devices indistinguishable from originals. Clear identification of the reprocessor as legal manufacturer ensures correct liability allocation, proper traceability and accurate incident reporting — preventing original manufacturers from being wrongly implicated in incidents caused by reprocessed devices.

Amendment 390

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

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.’;4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.’; For any reprocessed device placed on the market, the label shall clearly identify the reprocessor and indicate that the device has been reprocessed. When developing these common specifications, the Commission shall systematically consult the Medical Devices Coordination Group, notified bodies, manufacturers, healthcare professionals and patient representatives.

Or. fr

Amendment 391

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.;4. The Commission shall adopt, in accordance with Article 9(1), common specifications laying down general requirements and methodologies for the reprocessing of devices and the full refurbishment of single-use devices.

Or. en

Amendment 392

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.;4. The Commission shall adopt, in accordance with Article 9(1) and with the input of the expert panels, CS on general requirements regarding reprocessing of devices or fully refurbishing of single use devices.’;

Or. en

Amendment 393

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 2017/745

Article 17 – paragraph 4a (new)

Text proposed by the CommissionAmendment
4a. The Commission shall, by means of implementing acts, establish a list of categories of medical devices that, by their nature and having regard to hygiene, safety or performance considerations, are intended for single use and shall not be eligible for reprocessing. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). Devices included in that list shall be presumed to be intended for single use for the purposes of this Article, and manufacturers shall not be required to provide the grounds for that designation referred to in the first subparagraph.

Or. en

Amendment 394

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point a

Regulation (EU) 2017/745

Article 18 – paragraph 1

Text proposed by the CommissionAmendment
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, by any means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.;The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, by any means, including in electronic or digital format, that allow rapid and easy access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph. Where the information is provided in electronic or digital format, the manufacturer shall ensure that the patient may obtain, upon request and free of charge, a paper copy of that information.
Any electronic or digital means used to provide access to that information shall comply with Regulation (EU) 2016/679 and shall not permit the identification, profiling or tracking of patients beyond what is necessary for the provision of that information.

Or. en

Amendment 395

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point a

Regulation (EU) 2017/745

Article 18 – paragraph 1

Text proposed by the CommissionAmendment
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, by any means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.;The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, in paper format, and complementary to the mandatory paper format, by any additional means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.;

Or. en

Amendment 396

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point a

Regulation (EU) 2017/745

Article 18 – paragraph 1

Text proposed by the CommissionAmendment
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, by any means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.;The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, in paper format, and complementary to the mandatory paper format, by any additional means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.

Or. en

Amendment 397

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point a

Regulation (EU) 2017/745

Article 18 – paragraph 1

Text proposed by the CommissionAmendment
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, by any means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.;The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, in mandatory paper format, and by any additional means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.;

Or. en

Justification

Patients may have difficulty in access to digital format, for various reasons (accessibility issues, low digital literacy, lack of internet access...). Paper versions should remain obligatory.

Amendment 398

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point b

Regulation (EU) 2017/745

Article 18 – paragraph 3

Text proposed by the CommissionAmendment
(b) paragraph 3, is replaced by the following:deleted
‘3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article’;

Or. fr

Amendment 399

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point b

Regulation (EU) 2017/745

Article 18 – paragraph 3

Text proposed by the CommissionAmendment
(b) paragraph 3 is replaced by the following:deleted
‘3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article;’

Or. en

Amendment 400

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point b

Regulation (EU) 2017/745

Article 18 – paragraph 3

Text proposed by the CommissionAmendment
(b) paragraph 3 is replaced by the following:deleted
‘3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article;’

Or. en

Justification

Implant cards should remain mandatory for all implantable devices.

Amendment 401

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point b

Regulation (EU) 2017/745

Article 18 – paragraph 3

Text proposed by the CommissionAmendment
3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article;deleted

Or. en

Amendment 402

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point b

Regulation (EU) 2017/745

Article 18 – paragraph 3

Text proposed by the CommissionAmendment
3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article;3. The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom. In exercising that power, the Commission shall, in particular, consider adding implants that remain in the human body only temporarily or are fully resorbed by the human body. Class III implantable devices shall not be exempted pursuant to this paragraph

Or. en

Amendment 403

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

Proposal for a regulation

Article 1 – paragraph 1 – point 16 – point b

Regulation (EU) 2017/745

Article 18 – paragraph 3

Text proposed by the CommissionAmendment
3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article’;3. Implants that constitute well-established technological devices shall remain subject to the information requirements provided for in this Article. That information may be provided in electronic or digital format in accordance with paragraph 1.

Or. fr

Amendment 404

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 17 a (new)

Regulation (EU) 2017/745

Article 20 – paragraph 5

Present textAmendment
(17a) Article 20, paragraph 5 is replaced by the following:
Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking."The identification number of the notified body responsible for the conformity assessment procedures set out in Article 52 shall be part of the information to be submitted by the manufacturer to the UDI database in accordance with Article 29."

Or. en

(Regulation (EU) 2017/745)

Amendment 405

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 19 a (new)

Regulation (EU) 2017/745

Article 27 – paragraph 1 a (i)

Present textAmendment
Articolo 27, paragrafo 1a(i)‘Article 27, paragraph 1a(i)
1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
(a) production of a UDI that comprises the following:(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;(i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, either originally issued by the manufacturer or that has been lawfully made available to the manufacturer, providing access to the information laid down in Part B of Annex VI;’

Or. it

((EU) 2017/745)

Justification

Article 27 requires the UDI-DI to be specific to the manufacturer and the device. The addition clarifies that the requirement is also fulfilled when the UDI-DI has been assigned by another economic operator, provided that the manufacturer holds the exclusive right to use the UDI-DI and registers it in Eudamed. The amendment eases the way for mergers, acquisitions, and marketing under the company's own brand.

Amendment 406

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 20 – point a

Regulation (EU) 2017/745

Article 28 – paragraph 3

Text proposed by the CommissionAmendment
3. The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public, except the element referred to in point 13 of that Part..3. The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public, except the element referred to in point 12 of that Part..

Or. en

Amendment 407

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EU) 2017/745

Article 29 – paragraph 1

Text proposed by the CommissionAmendment
1. Before placing a device, other than a custom-made device or investigational device, on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device, as applicable. The manufacturer shall keep the information provided to the UDI database updated.1. Before placing a device, other than a custom-made device or investigational device, on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device, as applicable. The manufacturer shall keep the information provided to the UDI database updated and introduce any changes without undue delay and no later than one month after the change occurs.

Or. en

Amendment 408

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EU) 2017/745

Article 29 – paragraph 2

Text proposed by the CommissionAmendment
2. Before placing on the market a system or procedure pack as referred to in Article 22(1) and (3), the natural or legal person responsible shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack. The natural or legal person referred to in Article 22(1) shall keep up to date the information provided to the UDI database.2. Before placing on the market a system or procedure pack as referred to in Article 22(1) and (3), the natural or legal person responsible shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack. The natural or legal person referred to in Article 22(1) shall keep up to date the information provided to the UDI database and introduce any changes without undue delay and no later than one month after the change occurs.

Or. en

Amendment 409

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 24 – point a

Regulation (EU) 2017/745

Article 32 – paragraph 1

Text proposed by the CommissionAmendment
For class IIb implantable devices and for class III devices, other than custom-made or investigational devices and well-established technology devices, the manufacturer shall draw up a summary of safety and clinical performance.For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.

Or. en

Justification

Obligations for the summary of safety and clinical performance (SSCP) should not be removed for any class of implantable devices. Well-established technologies - list remains to be seen from the COM, and the SSCP should remain.

Amendment 410

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 24 – point a

Regulation (EU) 2017/745

Article 32 – paragraph 1

Text proposed by the CommissionAmendment
For class IIb implantable devices and for class III devices, other than custom-made or investigational devices and well-established technology devices, the manufacturer shall draw up a summary of safety and clinical performance.For class IIb implantable devices and for class IIb and class III devices, other than custom-made or investigational devices and well-established technology devices, the manufacturer shall draw up a summary of safety and clinical performance.

Or. en

Amendment 411

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 24 – point a

Regulation (EU) 2017/745

Article 32 – paragraph 1

Text proposed by the CommissionAmendment
For class IIb implantable devices and for class III devices, other than custom-made or investigational devices and well-established technology devices, the manufacturer shall draw up a summary of safety and clinical performance.For class IIb implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.

Or. en

Amendment 412

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

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 shall be made available to the public via Eudamed, in the official language or languages required by the Member State in which the device is made available.

Or. fr

Amendment 413

Tiemo Wölken

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 and understandable to the intended user and, where relevant to the patient as a lay person, and shall be made available to the public via Eudamed.

Or. en

Amendment 414

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

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, where the patient is also an intended user, to the patient, and shall be made available to the public via Eudamed.

Or. en

Amendment 415

Aurelijus Veryga

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 where the patient is also an intended user, to the patient, and shall be made available to the public via Eudamed.

Or. en

Amendment 416

Kateřina Konečná

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, if relevant, to the patient and shall be made available to the public via Eudamed.

Or. en

Amendment 417

Ruggero Razza, Michele Picaro

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 shall be made available to the public via Eudamed.

Or. it

Amendment 418

Valentina Palmisano

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 lay language and shall be made available to the public via Eudamed.

Or. en

Amendment 419

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 24 – point a

Regulation (EU) 2017/745

Article 32 – paragraph 1

Text proposed by the CommissionAmendment
The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52. The manufacturer shall ensure that the summary of safety and clinical performance is available in Eudamed as part of the information on the device to be provided pursuant to Article 29(1) and mention on the label or instructions for use where that summary is available.;The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52. Only the English language version of the SSCP shall be subject to validation by the notified body. The manufacturer shall ensure that the summary of safety and clinical performance is available in Eudamed as part of the information on the device to be provided pursuant to Article 29(1) and mention on the label or instructions for use where that summary is available. By default, only the English language version of the SSCP shall be provided. Translations into the other languages accepted in the Member States shall be provided upon request within a reasonable time frame.

Or. it

Justification

The aim is to reduce the financial and administrative burden of translating SSCPs (summaries of safety and clinical performance) into all EU languages, limiting mandatory translations to actual demand. Initially providing the SSCP in English would ease the burden on both manufacturers and the notified bodies, without reducing the safety requirements of the device.

Amendment 420

Kateřina Konečná

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 draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52. The manufacturer shall ensure that the summary of safety and clinical performance is available in Eudamed as part of the information on the device to be provided pursuant to Article 29(1) and mention on the label or instructions for use where that summary is available.;The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52. The manufacturer shall ensure that the summary of safety and clinical performance is available in Eudamed as part of the information on the device to be provided pursuant to Article 29(1) and mention provide a direct link or QR code on the label or instructions for use to where that summary is available.

Or. en

Amendment 421

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 24 – point b

Regulation (EU) 2017/745

Article 32 – paragraph 2 – point h

Text proposed by the CommissionAmendment
(h) information on any residual risks or undesirable effects, and any warnings and precautions.’;(h) information on any residual risks or undesirable effects, and any warnings and precautions, as well as the absence of identified endocrine disruptors in parts likely to be transferred to the patient;

Or. fr

Justification

The design work carried out to avoid the presence of endocrine disruptors must be recognised in order to drive innovation and competitive advantage.

Amendment 422

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 25 – point d

Regulation (EU) 2017/745

Article 33 – paragraph 5 – subparagraphs 1 and 2

Text proposed by the CommissionAmendment
All the information collated and processed by Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.All the information collated and processed by Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2. Restrictions to public access shall be limited to what is strictly necessary and justified on the grounds of personal data protection, the protection of commercially confidential information, or the protection of public health. The protection of commercially confidential information shall be balanced against the need to ensure a high level of transparency and the availability of information necessary for patients and healthcare professionals to assess the safety and performance of devices. The Commission shall ensure that public parts of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, are presented in a user-friendly and easily-searchable format. In doing so, it shall consult with patient and healthcare professional organisations;

Or. en

Amendment 423

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 25 – point d

Regulation (EU) 2017/745

Article 33 – paragraph 5 – subparagraph 1

Text proposed by the CommissionAmendment
All the information collated and processed by Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.All the information collated and processed by Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2. Restrictions to public access shall be limited to what is strictly necessary and justified on the grounds of personal data protection, the protection of commercially confidential information, or the protection of public health. The protection of commercially confidential information shall be balanced against the need to ensure a high level of transparency and the availability of information necessary for patients and healthcare professionals to assess the safety and performance of devices.

Or. en

Amendment 424

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

Proposal for a regulation

Article 1 – paragraph 1 – point 25 – point d

Regulation (EU) 2017/745

Article 33 – paragraph 5 – subparagraph 2

Text proposed by the CommissionAmendment
The Commission shall ensure that public parts of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, are presented in a user-friendly and easily-searchable format.’;The Commission shall ensure that public parts of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, are accessible in all official languages of the Union, easy for non-experts to use and easily consultable and searchable.’;

Or. fr

Amendment 425

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 25 – point d

Regulation (EU) 2017/745

Article 33 – paragraph 5 – subparagraph 2

Text proposed by the CommissionAmendment
The Commission shall ensure that public parts of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, are presented in a user-friendly and easily-searchable format.;The Commission shall ensure that public parts of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, are presented in a user-friendly, easily-searchable and accessible format and that information made available to the public is worded in an appropriate and comprehensive manner.

Or. en

Amendment 426

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 27 – point b

Regulation (EU) 2017/745

Article 35 – paragraph 8

Text proposed by the CommissionAmendment
(b) paragraph 8 is replaced by the following:deleted
‘8. The authorities responsible for notified bodies shall coordinate their activities to be carried out in accordance with this Chapter, cooperate with each other and with the Commission and resolve issues of diverging opinions between themselves to ensure a harmonised application of the requirements relating to notified bodies.;’

Or. en

Justification

The Commission is removing references to article 48 (peer-review) and is also hollowing out article 48 further down.

Amendment 427

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 28 – point a a (new)

Regulation (EU) 2017/745

Article 36 – paragraph 1a (new)

Text proposed by the CommissionAmendment
(aa) Within the Union, notified bodies shall be allowed to equally recognise and rely upon assessments and evidence that have already been evaluated, whether by the same or another designated notified body.

Or. en

Justification

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

Amendment 428

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 28 – point b

Regulation (EU) 2017/745

Article 36 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend Annex VII in order to adapt to technical or scientific progress regarding conformity assessment in the field of medical devices, including developments at international level.’;deleted

Or. fr

Amendment 429

Ruggero Razza

Proposal for a regulation

Article 1 – paragraph 1 – point 28 – point b

Regulation (EU) 2017/745

Article 36 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend Annex VII in order to adapt to technical or scientific progress regarding conformity assessment in the field of medical devices, including developments at international level.’;deleted

Or. fr

Amendment 430

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 32

Regulation (EU) 2017/745

Article 40a – paragraph 1

Text proposed by the CommissionAmendment
1. Conformity assessment bodies and notified bodies shall pay a fee for the assessment of their application for designation and their monitoring, including the costs for the involvement of experts nominated in accordance with Article 40 in those assessment and monitoring activities.1. Conformity assessment bodies and notified bodies shall pay a fee to the authority responsible for notified bodies for the assessment of their application for designation and their monitoring, including the costs for the involvement of experts nominated in accordance with Article 40 in those assessment and monitoring activities.

Or. en

Amendment 431

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

Proposal for a regulation

Article 1 – paragraph 1 – point 35 – point j

Regulation (EU) 2017/745

Article 44 – paragraph 12

Text proposed by the CommissionAmendment
12. The authority responsible for notified bodies shall draw up an annual summary of their monitoring activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. That summary shall be made publicly available through the electronic system referred to in Article 57.’;12. The authority responsible for notified bodies shall draw up an annual summary of their monitoring activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. It shall include a chapter on the compliance by each notified body with Article 49 of this Regulation in order to assess the conformity of the decisions taken with regard to the MDCG guidance. That summary shall be made publicly available through the electronic system referred to in Article 57.’;

Or. fr

Amendment 432

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 39

Regulation (EU) 2017/745

Article 48

Text proposed by the CommissionAmendment
(39) Article 48 is amended as follows:deleted
(a) the title is replaced by the following:
‘Exchange of experience between authorities responsible for notified bodies;’

Or. en

Justification

Significantly weakening the role of peer-review.

Amendment 433

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

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 49 – paragraph 1

Text proposed by the CommissionAmendment
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. The coordination group shall meet on a regular basis, at least annually, and report to the MDCG.The Commission and the authorities responsible for notified bodies shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. The coordination group shall meet on a regular basis, at least annually, and report to the MDCG.

Or. fr

Amendment 434

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 49 – paragraph 3

Text proposed by the CommissionAmendment
3. All bodies notified under this Regulation and under Regulation (EU) 2017/746 shall actively participate in the work of the coordination group to support the implementation of this Regulation and of Regulation (EU) 2017/746 by sharing experience and developing common templates and technical guidance to facilitate harmonisation and common approaches regarding conformity assessment activities. They shall cooperate with each other, with the Commission, with the relevant authorities of the Member States, with expert panels and, where applicable, expert laboratories or European Union reference laboratories to ensure a harmonised application of the requirements set out in this Regulation and in Regulation (EU) 2017/746.3. All bodies notified under this Regulation and under Regulation (EU) 2017/746 shall actively participate in the work of the coordination group to support the implementation of this Regulation and of Regulation (EU) 2017/746 by sharing experience and developing common templates and technical guidance to facilitate harmonisation and common approaches regarding conformity assessment activities. They shall cooperate with each other, with the Commission, with the relevant authorities of the Member States, with expert panels and, where applicable, expert laboratories or European Union reference laboratories to ensure a harmonised application of the requirements set out in this Regulation and in Regulation (EU) 2017/746. The governance structure of notified bodies shall be strengthened to ensure a level of harmonisation, consistency and interoperability.

Or. en

Justification

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

Amendment 435

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

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 49 – paragraph 4 a (new)

Text proposed by the CommissionAmendment
4a. As part of the annual summary of the monitoring activities of notified bodies, the authority responsible for notified bodies in each Member State shall devote a chapter to compliance with this Article. That chapter shall identify cases where the notified bodies under its oversight have manifestly failed to comply with the obligations laid down in this Article or have failed to take due account of the relevant MDCG guidance, as well as any other manifest cases that have led to a non-harmonised application of this Regulation or Regulation (EU) 2017/746.

Or. fr

Amendment 436

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

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. 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. Notified bodies shall apply at least a 10 % fee reduction for manufacturers who demonstrate that the medical device concerned is manufactured or produced in the European Union and that a substantial share of it is of European origin. A share shall be considered substantial where at least 50 % of the value of the medical device comes from components originating in the European Union.

Or. fr

Amendment 437

Laurence Trochu

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. Member States may consider introducing accounting and/or tax measures to reduce the financial burden of fees for notified bodies by at least 50 % 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, at least a 50 % fee reduction for manufacturers that apply for conformity assessment of an orphan device referred to in Article 52a(3), at least 50 % for paediatric devices and at least 25 % for medical devices free of identified endocrine disruptors that can be transferred to patients. Notified bodies may 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.

Or. fr

Justification

In order to ensure fair access to notified bodies for small companies and/or paediatric devices or devices which are free of endocrine disruptors, and therefore rapid access to the market, it is essential that the profitability of notified bodies is not compromised by such services, which, moreover, are particularly likely to be more time-consuming for experts.

Amendment 438

Kateřina Konečná

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. 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) or a paediatric device referred to in Article 52a(4). 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.

Or. en

Amendment 439

Tiemo Wölken

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 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 440

Andreas Glück, Stine Bosse, Billy Kelleher

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. Notified bodies shall apply a fee reduction up to 50 % for manufacturers that are micro enterprises within the meaning of Recommendation 2003/361/EC and up to 50 % fee reduction for small enterprises within the meaning of that Recommendation. They shall apply a fee reduction up to 50 % 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.

Or. en

Justification

Fee reductions for micro and small enterprises and manufacturers of orphan devices support access to conformity assessment without undermining the financial sustainability of notified bodies. Replacing mandatory minimum reductions with a ceiling of 'up to 50%' gives notified bodies the flexibility to calibrate reductions according to their cost structures, while ensuring SMEs and orphan device manufacturers benefit from meaningful support. The payment deferral option further reduces the immediate financial burden on smaller manufacturers without imposing fixed costs on notified bodies.

Amendment 441

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 3

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:deleted
(a) establish and maintain high standards of quality and safety of devices;
(b) ensure the availability of devices;
(c) protect the interests of micro, small or medium-sized enterprises within the meaning of Recommendation 2003/361/EC;
(d) support innovation and competitiveness.

Or. fr

Amendment 442

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 3

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 and other relevant stakeholders, 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 443

Tiemo Wölken

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 444

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

Proposal for a regulation

Article 1 – paragraph 1 – point 40

Regulation (EU) 2017/745

Article 50 – paragraph 3 – point d a (new)

Text proposed by the CommissionAmendment
(da) promote production capacity within the EU and strengthen the resilience of its medical technology supply chain

Or. fr

Amendment 445

Tiemo Wölken

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 446

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 41 – point a

Regulation (EU) 2017/745

Article 51 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. During the validity period of the certificate, the notified body shall carry out surveillance activities only to the extent provided for in the annex applicable to the conformity assessment on the basis of which the certificate was issued (Annex IX, Annex X or Annex XI). Those surveillance activities shall be proportionate to the risk class of the device and shall not constitute a re-evaluation equivalent in scope to the conformity assessment carried out for the issuance of the certificate.

Or. it

Amendment 447

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

Proposal for a regulation

Article 1 – paragraph 1 – point 42

Regulation (EU) 2017/745

Article 51a – paragraph 3

Text proposed by the CommissionAmendment
3. Where, within 30 days of receipt of the consultation referred to in the paragraph 2, no substantiated disagreement is raised by a Member State, the competent authority shall adopt its decision within 90 days of receipt of the referral referred to in paragraph 1.3. Where, within 30 days of receipt of the consultation referred to in the paragraph 2, no substantiated disagreement is raised by a Member State, the competent authority shall adopt its decision within 60 days of receipt of the referral referred to in paragraph 1.

Or. fr

Amendment 448

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point a

Regulation (EU) 2017/745

Article 52 – paragraph 3

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

Justification

The current ‘sampling’ approach to technical documentation review should not be made more flexible. Class III devices are high risk. No devices in that category should be placed on the market without review of their product-specific technical documentation

Amendment 449

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

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. en

Justification

Here some flexible sampling is already the status quo, and need not be made more flexible.

Amendment 450

Tiemo Wölken

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, one representative device per each category of devices.

Or. en

Amendment 451

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
(c) paragraph 5 is deleted;(c) In Article 61, paragraph 5 is replaced by the following:
A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
— the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and
— the original clinical evaluation has been performed in compliance with the requirements of this Regulation, and the manufacturer of the second device provides clear evidence thereof to the notified body.

Or. en

Amendment 452

Tiemo Wölken

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 453

Tiemo Wölken

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 454

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point g

Regulation (EU) 2017/745

Article 52 – paragraph 14 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects for any of the following aspects:The Commission shall, by means of implementing acts, and after consultation with relevant stakeholder, specify detailed arrangements and procedural aspects for the following aspects:

Or. en

Amendment 455

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point g

Regulation (EU) 2017/745

Article 52 – paragraph 14 – subparagraph 1 – point d

Text proposed by the CommissionAmendment
(d) the modalities of the conformity assessment procedures regarding breakthrough devices and orphan devices set out in Article 52a;;(d) the modalities of the conformity assessment procedures regarding breakthrough devices and orphan devices, and paediatric devices set out in Article 52a;’;

Or. en

Amendment 456

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point g

Regulation (EU) 2017/745

Article 52 – paragraph 14 – subparagraph 1 – point d

Text proposed by the CommissionAmendment
(d) the modalities of the conformity assessment procedures regarding breakthrough devices and orphan devices set out in Article 52a;;(d) the modalities of the conformity assessment procedures regarding breakthrough device, orphan devices and paediatric devices set out in Article 52a;;

Or. en

Amendment 457

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point h

Regulation (EU) 2017/745

Article 52 – paragraph 15

Text proposed by the CommissionAmendment
(h) the following paragraph 15 is added:deleted
‘15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annexes IX, X, XI and XIII in order to adapt to technical or scientific progress or to developments regarding conformity assessment of devices at international level and to take into account the needs of particular devices in view of their special characteristics.’;

Or. fr

Amendment 458

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point h

Regulation (EU) 2017/745

Article 52 –paragraph 15

Text proposed by the CommissionAmendment
15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annexes IX, X, XI and XIII in order to adapt to technical or scientific progress or to developments regarding conformity assessment of devices at international level and to take into account the needs of particular devices in view of their special characteristics.;deleted

Or. en

Amendment 459

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

Proposal for a regulation

Article 1 – paragraph 1 – point 43 – point h

Regulation (EU) 2017/745

Article 52 – paragraph 15

Text proposed by the CommissionAmendment
15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annexes IX, X, XI and XIII in order to adapt to technical or scientific progress or to developments regarding conformity assessment of devices at international level and to take into account the needs of particular devices in view of their special characteristics.’;15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annexes IX, X, XI and XIII in order to adapt to technical or scientific progress or to developments regarding conformity assessment of devices at international level and to take into account the needs of particular devices in view of their special characteristics.’; The Commission shall consult the MDCG, notified bodies, patient organisations and manufacturers;

Or. fr

Amendment 460

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – title

Text proposed by the CommissionAmendment
Conformity assessment of breakthrough devices and of orphan devicesConformity assessment of breakthrough devices, of paediatric devices and of orphan devices

Or. en

Amendment 461

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

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52 a – paragraph 1

Text proposed by the CommissionAmendment
1. For the conformity assessment of breakthrough devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.1. For the conformity assessment of breakthrough devices, paediatric devices and orphan devices, including in vitro diagnostic orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.

Or. fr

Amendment 462

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a– paragraph 1

Text proposed by the CommissionAmendment
1. For the conformity assessment of breakthrough devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.1. For the conformity assessment of breakthrough devices, paediatric devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.

Or. en

Amendment 463

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 1

Text proposed by the CommissionAmendment
1. For the conformity assessment of breakthrough devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.1. For the conformity assessment of breakthrough devices orphan devices, and paediatric devices for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.

Or. en

Justification

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

Amendment 464

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52 a – paragraph 1

Text proposed by the CommissionAmendment
1. For the conformity assessment of breakthrough devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.1. For the conformity assessment of breakthrough devices, paediatric and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article.

Or. en

Justification

Not all paediatric devices will fall into the categories of orphan, breakthrough or niche, therefore we suggest including also paediatric considerations here in paragraph 1 and all throughout the article 52a, to make sure all paediatric devices both are covered and their specificities can be supported

Amendment 465

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 2

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

Or. en

Amendment 466

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 2 – point b – point i

Text proposed by the CommissionAmendment
(i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art;(i) offering a significant positive clinical benefit or health impact compared to available alternatives and the state of the art;

Or. en

Amendment 467

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 2 – point b – point ii

Text proposed by the CommissionAmendment
(ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.(ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose or where the available alternatives do not adequately address the medical needs of the target patient population.

Or. en

Amendment 468

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 2 – point ba (new)

Text proposed by the CommissionAmendment
(ba) It has already undergone initial testing, the assessment of which indicates that the clinical benefits of assigning it to the category of breakthrough devices outweigh the risks.

Or. en

Amendment 469

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 3

Text proposed by the CommissionAmendment
3. A device shall be considered an orphan device if it meets the following criteria:deleted
(a) it is intended for the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12 000 individuals in the Union per year;
(b) at least one of the following criteria is met:
(i) there are insufficient available alternatives;
(ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art, taking into account both device-specific factors and patient population-specific factors.

Or. en

Amendment 470

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 4 (new)

Text proposed by the CommissionAmendment
3a. 4. A device shall be considered a paediatric device if it meets the following criteria:
(a) it is intended for the treatment, diagnosis, or prevention of a disease or condition in children under 18;
(b) at least one of the following criteria is met:
(i) there are insufficient available alternatives;
(ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art, taking into account both device-specific factors and patient population-specific factors.

Or. en

Amendment 471

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 4

Text proposed by the CommissionAmendment
4. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria set out in paragraph 2 or 3 of this Article, as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.4. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria defined in the definitions of a breakthrough, orphan and paediatric devices, as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.

Or. en

Justification

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

Amendment 472

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

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52 a – paragraph 4

Text proposed by the CommissionAmendment
4. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria set out in paragraph 2 or 3 of this Article, as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.4. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria set out in paragraph 2 or 3 of this Article, or in Article 2(82), as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.

Or. fr

Amendment 473

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 4

Text proposed by the CommissionAmendment
4. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria set out in paragraph 2 or 3 of this Article, as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.4. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria set out in paragraph 2, 3 and 4 of this Article, as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.

Or. en

Amendment 474

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a –paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device, including scientific and regulatory advice throughout the development of the device. Where appropriate, the expert panel shall coordinate with the notified body concerned in order to facilitate a coordinated approach to the conformity assessment of the device.

Or. en

Amendment 475

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria defined in the definitions of a breakthrough, orphan and paediatric devices, the manufacturer of a breakthrough device, of an orphan device, or paediatric device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.

Or. en

Justification

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

Amendment 476

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device and the sponsor of the clinical trial(s), as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.

Or. en

Amendment 477

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2, 3 and 4 of this Article, the manufacturer of a breakthrough device, paediatric device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.

Or. en

Amendment 478

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6 – subparagraph 1

Text proposed by the CommissionAmendment
For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines.For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines, while ensuring that the conformity assessment remains scientifically robust and that the applicable requirements of this Regulation continue to be fulfilled.

Or. en

Amendment 479

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6 – subparagraph 1

Text proposed by the CommissionAmendment
For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines.For a confirmed breakthrough device, an orphan device, or paediatric device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines.

Or. en

Justification

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

Amendment 480

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6 – subparagraph 1

Text proposed by the CommissionAmendment
For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines.For a confirmed breakthrough device, paediatric device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines.

Or. en

Amendment 481

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6 – subparagraph 2

Text proposed by the CommissionAmendment
The notified body shall give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.The notified body shall give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided. Where the notified body has not followed the recommendations expressed in the opinion or advice, the expert panel may request additional information or clarification on reasons provided by the notified body.

Or. en

Justification

This provision intends to improve dialogue between expert panels and notified bodies.

Amendment 482

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6 – subparagraph 2

Text proposed by the CommissionAmendment
The notified body shall give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.The notified body shall give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide a publicly available report including a comprehensive explanation of the reasons for not following the opinion or advice, and scientifically robust justifications for its decision. The notified body may ask the expert panel to clarify the opinion it has provided.

Or. en

Amendment 483

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6 – subparagraph 2

Text proposed by the CommissionAmendment
The notified body shall give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.The notified body shall be able to participate in the provision of joint advice set out in paragraph 5 and give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.

Or. en

Amendment 484

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 6a (new)

Text proposed by the CommissionAmendment
6a. For companion diagnostics and drug device products, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment and apply, where appropriate, a rolling review with a view to reduce assessment timelines to align with the accelerated review timelines for the corresponding medicinal product. The notified body shall in this case provide expedited approval timelines to avoid a lack of patient access to the corresponding medicinal product.

Or. en

Amendment 485

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 7 – subparagraph 1

Text proposed by the CommissionAmendment
The notified body shall issue a certificate pursuant to Article 56 where the pre-market clinical evidence, even if based on limited clinical data, is deemed adequate, provided that either of the following conditions is fulfilled:The notified body shall issue a certificate pursuant to Article 56 where the pre-market clinical evidence is deemed adequate, provided that all of the following conditions are fulfilled:

Or. en

Amendment 486

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 7 – subparagraph 1

Text proposed by the CommissionAmendment
The notified body shall issue a certificate pursuant to Article 56 where the pre-market clinical evidence, even if based on limited clinical data, is deemed adequate, provided that either of the following conditions is fulfilled:The notified body shall issue a certificate pursuant to Article 56 where the pre-market clinical evidence, even if based on limited clinical data, is deemed adequate, provided that the following conditions is fulfilled:

Or. en

Amendment 487

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 7 – point b

Text proposed by the CommissionAmendment
(b) the benefit-risk-ratio of the device is favourable and the manufacturer commits to providing additional data from post-market clinical follow-up activities.(b) the benefit-risk-ratio of the device is favourable and the manufacturer commits to providing additional data from post-market clinical follow-up activities, in accordance with a post-market clinical follow-up plan containing appropriate milestones and timelines for the generation of additional clinical evidence..

Or. en

Amendment 488

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time.The notified body shall limit the validity of the initial certificate to a maximum of five years and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time. Where the manufacturer fails to fulfil the post-market clinical follow-up obligations attached to the certificate within the specified timeframe, the certificate shall not be renewed by the notified body. The notified body shall only extend the validity of the certificate, following an assessment performed in accordance with Annex VII, Section 4.11.

Or. en

Amendment 489

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52 a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time.Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time and, except in the case of a life-threatening medical emergency, the informed consent of each patient must be duly obtained prior to the prescription or use of a device placed on the market in accordance with this Article.

Or. fr

Amendment 490

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time.For breakthrough devices and where appropriate for orphan devices, the notified body shall limit the time of validity for the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time.

Or. en

Amendment 491

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 8

Text proposed by the CommissionAmendment
8. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend this Article to adapt to technical or scientific progress or to take into account developments regarding conformity assessment of breakthrough devices or orphan devices at international level.8. The Commission is empowered to adopt delegated acts in accordance with Article 16 115 in order to amend this Article to adapt to technical or scientific progress or to take into account developments regarding conformity assessment of breakthrough devices, paediatric devices or orphan devices at international level.

Or. en

Amendment 492

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 8

Text proposed by the CommissionAmendment
8. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend this Article to adapt to technical or scientific progress or to take into account developments regarding conformity assessment of breakthrough devices or orphan devices at international level.8. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend this Article to adapt to technical or scientific progress or to take into account developments regarding conformity assessment of breakthrough devices, orphan devices, or paediatric devices at international level.

Or. en

Justification

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

Amendment 493

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 9

Text proposed by the CommissionAmendment
9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article, including arrangements for rolling review, interactions with expert panels and procedural timelines for prioritized assessments. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Or. en

Amendment 494

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 9

Text proposed by the CommissionAmendment
9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices, orphan devices or paediatric devices, set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Or. en

Justification

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

Amendment 495

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 9

Text proposed by the CommissionAmendment
9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices, paediatric devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Or. en

Amendment 496

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 44

Regulation (EU) 2017/745

Article 52a – paragraph 9a (new)

Text proposed by the CommissionAmendment
9a. The Commission may, by means of implementing acts, lay down requirements for the preparation of a paediatric development plan, for categories or groups of devices which are marketed for adults, but may have clinical benefit for paediatrics or the treatment of rare diseases. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Or. en

Amendment 497

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 46

Regulation (EU) 2017/745

Article 54 – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
In addition to the procedures applicable pursuant to Article 52, a notified body shall follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of class III implantable devices, other than custom-made devices.In addition to the procedures applicable pursuant to Article 52, a notified body shall follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of class III implantable devices, other than custom-made devices, implantable class III breakthrough devices and orphan devices and niche devices as referred to in Article 52a of this Regulation.

Or. en

Amendment 498

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

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 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. Where the notified body has not followed the opinion issued by the expert panel, the expert panel may request additional information or clarification on reasons provided by the notified body.

Or. en

Justification

This provision intends to improve dialogue between expert panels and notified bodies.

Amendment 499

Tiemo Wölken

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 the 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 or recommendations expressed by the expert panel in that opinion, it shall provide a substantiated justification for its decision and transmit 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. Where the notified body has not followed the views or recommendations by the expert panel, its justification shall also be made available via EUDAMED.

Or. en

Amendment 500

Valentina Palmisano

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 501

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 46

Regulation (EU) 2017/745

Article 55 – paragraph 3

Text proposed by the CommissionAmendment
3. The notified body shall give utmost consideration to the advice provided by the expert panel or the expert laboratory and, where needed, take any appropriate measures, including those referred to in Article 56(3) and (4).;3. The notified body shall give the utmost consideration to the advice provided by the expert panel or the expert laboratory and, where needed, take any appropriate measures, including those referred to in Article 56(3) and (4).;

Or. en

Amendment 502

Tiemo Wölken

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 503

Valentina Palmisano

on behalf of The Left Group

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.deleted

Or. en

Amendment 504

Kateřina Konečná

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 validity of certificates shall not be limited in time, except for class IIb implantable and class III devices for which certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
For other class I and class II devices, the duration of certificates may be limited 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.’

Or. en

Amendment 505

Laurence Trochu

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 validity of certificates shall not be limited in time, except for the highest-risk implantable devices, for which the notified body may authorise a maximum duration of 10 years, and 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.’;

Or. fr

Amendment 506

Tiemo Wölken

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 a certification extension, taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.
Those periodic reviews shall not require a complete reassessment of the conformity assessment previously carried out, unless such reassessment is duly justified by significant changes affecting the device, newly identified risks, or concerns relating to the safety of patients or users.

Or. en

Amendment 507

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point b

Regulation (EU) 2017/745

Article 56 – paragraph 2 a

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 surveillance activities only to the extent provided for in the annex applicable to the conformity assessment on the basis of which the certificate was issued (Annex IX, Annex X or Annex XI). Those surveillance activities shall be proportionate to the risk class of the device and shall not constitute a re-evaluation equivalent in scope to the conformity assessment carried out for the issuance of the certificate.

Or. it

Justification

The MDR certification system already provides for continuous monitoring of certificates, quality management systems and technical documentation, following an approach based on quality assurance, not control. Additional periodic reviews not defined by the Commission proposal would constitute an overlap in red tape with no real added safety value. Surveillance should remain proportionate to the device, the risk class and the applicable annexes.

Amendment 508

Stine Bosse, Billy Kelleher

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 taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.
Those periodic reviews shall not constitute a re-assessment of elements already assessed during the initial conformity assessment or previous reviews, unless duly justified by significant changes or new risks.;

Or. en

Justification

This amendment ensures proportionality, predictability and efficient use of notified body resources, while maintaining a high level of patient safety.

Clarifying that periodic reviews shall not re-assess elements already evaluated avoids duplicative assessments during the certificate validity period. Without this clarification, the provision risks creating unnecessary administrative burden, longer timelines and reduced system capacity.

At the same time, the amendment fully preserves the existing high level of patient safety by explicitly allowing re-assessment where justified by significant changes or new risks, in line with a lifecycle and risk-based approach. This text reinforces a predictable and proportionate oversight system, supports timely patient access, and safeguards the integrity of the MDR framework in line with the political intention of the Commission's proposal.

Amendment 509

Aurelijus Veryga

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 taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device. Those periodic reviews shall not constitute a re-assessment of elements already assessed during the initial conformity assessment or previous reviews, unless duly justified by significant changes or new risks.;

Or. en

Amendment 510

Viktória Ferenc

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 taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device. Those periodic reviews shall not constitute a re-assessment of elements already assessed during the initial conformity assessment or previous reviews, unless duly justified by significant changes or new risks.;

Or. en

Justification

Clarifying that periodic reviews shall not re-assess elements already evaluated avoids duplicative assessments and prevents de facto “recertification by stealth” during the certificate validity period. Without this clarification, the provision risks creating unnecessary administrative burden, longer timelines and reduced system capacity.

At the same time, the amendment fully preserves safety by explicitly allowing re-assessment where justified by significant changes or new risks, in line with a lifecycle, risk-based approach.

Amendment 511

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

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 surveillance activities solely as set out in the Annex applicable to the conformity assessment under which the certificate was issued (Annex IX, Annex X or Annex XI). These surveillance activities shall be proportionate to the risk class of the device and shall not amount to a reassessment equivalent in scope to the conformity assessment carried out for the issuance of the certificate.

Or. en

Amendment 512

Kateřina Konečná

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 taking into consideration developments of the state of the art, Post-Market Surveillance and vigilance data, and relevant data from clinical registries and other real-world evidence sources. Those reviews shall be documented and proportionate to the risk class of the device.

Or. en

Amendment 513

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point b

Regulation (EU) 2017/745

Article 56 – paragraph 2 aa (new)

Text proposed by the CommissionAmendment
2aa. By way of derogation from the first paragraph, certificates issued for devices containing substances referred to in Section 10.4.2 of Annex I shall remain valid for a maximum period of five years and shall not be eligible for certification without a specified period of validity. Such devices shall undergo a renewed conformity assessment at least every five years or earlier where new scientific evidence indicates that the safety or performance of the device, or the risks associated with the substances concerned, may be adversely affected.

Or. en

Amendment 514

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

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point b

Regulation (EU) 2017/745

Article 56 – paragraph 2 a – subparagraph 1 a (new)

Text proposed by the CommissionAmendment
2aa. Such periodic reviews shall not constitute a reassessment of elements already assessed during the initial conformity assessment or previous reviews, unless duly justified by significant changes or new risks.’;

Or. fr

Amendment 515

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point c

Regulation (EU) 2017/745

Article 56 – paragraph 3

Text proposed by the CommissionAmendment
3. Notified bodies may impose conditions on the validity of the certificate, such as limiting the intended purpose of a device to certain groups of patients or requiring the manufacturer to undertake specific PMCF studies pursuant to Part B of Annex XIV.;3. Notified bodies may impose conditions on the validity of the certificate, such as limiting the intended purpose of a device to certain groups of patients or requiring the manufacturer to undertake specific PMCF studies pursuant to Part B of Annex XIV. The validity of the initial certificate for breakthrough and orphan devices shall be limited to a maximum of five years.

Or. en

Amendment 516

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point d

Regulation (EU) 2017/745

Article 56 – paragraph 4

Text proposed by the CommissionAmendment
(d) in paragraph 4, the first sentence is replaced by the following:deleted
‘Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.;’

Or. en

Amendment 517

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

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point d

Regulation (EU) 2017/745

Article 56 – paragraph 4

Text proposed by the CommissionAmendment
‘Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.’;‘Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. Before suspending or withdrawing a certificate, the notified body must give the manufacturer the opportunity to submit observations and propose corrective measures, except where immediate action is necessary to remedy a significant risk to health or safety.’

Or. fr

Amendment 518

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point d

Regulation (EU) 2017/745

Article 56 – paragraph 4

Text proposed by the CommissionAmendment
Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.;Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer or where the requirements set out in paragraph 3 are not fulfilled, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision.

Or. en

Amendment 519

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point d

Regulation (EU) 2017/745

Article 56 – paragraph 4 a (new)

Text proposed by the CommissionAmendment
Where a medical device has undergone the conformity assessment referred to in Article 52 with the involvement of a notified body and bears the CE marking in accordance with Article 20, that device shall be presumed, throughout the validity period of its certificate, to comply with all the requirements of this Regulation. That presumption may only be rebutted if there is clear evidence to the contrary. When applying or enforcing any national measure, Member States shall ensure that those national measures do not lead to the device being further assessed for its conformity with the general safety and performance requirements set out in Annex I.

Or. it

Amendment 520

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 47 – point d

Regulation (EU) 2017/745

Article 56 – paragraph 4a (new)

Text proposed by the CommissionAmendment
A medical device that has undergone the conformity assessment referred to in Article 52 with the involvement of a notified body and bears the CE marking in accordance with Article 20 shall, throughout the period of validity of its certificate, benefit from a presumption of conformity with all the requirements of this Regulation, which may be rebutted only by clear evidence to the contrary. When enforcing any national rule, Member States shall not subject such a device to a renewed assessment of its conformity with the General Safety and Performance Requirements laid down in Annex I.

Or. en

Amendment 521

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 48 a (new)

Regulation (EU) 2017/745

Article 58 – paragraph 3 (new)

Present textAmendment
(48a) paragrapgh (3 new) shall be added to Article 58 - Voluntary change of notified body
paragrapgh (3 new) shall be added to Article 58 - Voluntary change of notified body"Where a manufacturer changes its notified body in accordance with this Article, the outgoing notified body shall, upon request of the manufacturer, transfer to the new notified body all documentation and information necessary for the continuity of the conformity assessment and surveillance activities. Such transfer shall be carried out without undue delay and subject to appropriate arrangements to ensure confidentiality. The outgoing notified body may charge a proportionate fee reflecting the administrative costs incurred in carrying out the transfer."

Or. en

(Regulation (EU) 2017/745)

Amendment 522

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point a

Regulation (EU) 2017/745

Article 59 – paragraph 1

Text proposed by the CommissionAmendment
1. By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health.’;1. By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health.’; In the event of harm caused to professionals or patients whilst using a device authorised in this way, the Member State must advance the compensation to which the victims are entitled without waiting for a final determination of liability between the manufacturer and the competent authority’,

Or. fr

Amendment 523

Andreas Glück, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point a

Regulation (EU) 2017/745

Article 59 – paragraph 1

Text proposed by the CommissionAmendment
1. By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health.;1. By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health, or is necessary for national security or defence purposes.;

Or. en

Justification

Armed forces may need urgent access to essential devices for deployment or crisis response where no MDR-compliant device is available in time. Adds national security/defence as a derogation ground, protects classified information from publication, and enables EU-wide extension for multinational operations.

Amendment 524

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point a

Regulation (EU) 2017/745

Article 59 – paragraph 1

Text proposed by the CommissionAmendment
1. By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health.;1. By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device or category of devices for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health.;

Or. en

Amendment 525

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point b

Regulation (EU) 2017/745

Article 59 – paragraph 1 a

Text proposed by the CommissionAmendment
1 a. By way of derogation from Article 6(2) and on a duly justified request, any competent authority may authorise for a limited period of time the provision of a diagnostic or therapeutic service referred to in that Article to a natural or legal person established within the territory of the Member State concerned, using a device for which the applicable conformity assessment procedures set out in this Regulation have not been carried out, provided the provision of such service is in the interest of public health, patient safety or patient health.’;1 a. By way of derogation from Article 6(2) and on a duly justified request, any competent authority may authorise for a limited period of time the provision of a diagnostic or therapeutic service referred to in that Article to a natural or legal person established within the territory of the Member State concerned, using a device for which the applicable conformity assessment procedures set out in this Regulation have not been carried out, provided the provision of such service is in the interest of public health, patient safety or patient health. In the event of harm caused to professionals or patients whilst using a device authorised in this way, the Member State must advance the compensation to which the victims are entitled without waiting for a final determination of liability between the manufacturer and the competent authority.’;

Or. fr

Amendment 526

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

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point b

Regulation (EU) 2017/745

Article 59 – paragraph 1 a

Text proposed by the CommissionAmendment
1 a. By way of derogation from Article 6(2) and on a duly justified request, any competent authority may authorise for a limited period of time the provision of a diagnostic or therapeutic service referred to in that Article to a natural or legal person established within the territory of the Member State concerned, using a device for which the applicable conformity assessment procedures set out in this Regulation have not been carried out, provided the provision of such service is in the interest of public health, patient safety or patient health.’;1 a. By way of derogation from Article 6(2) and on a duly justified request, any competent authority may authorise for a renewable period of 24 months, the provision of a diagnostic or therapeutic service referred to in that Article to a natural or legal person established within the territory of the Member State concerned, using a device or a category of devices for which the applicable conformity assessment procedures set out in this Regulation have not been carried out, provided the provision of such service is in the interest of public health, patient safety or patient health.’;

Or. fr

Amendment 527

Andreas Glück, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point c

Regulation (EU) 2017/745

Article 59 – paragraph 2 – subparagraph 2a (new)

Text proposed by the CommissionAmendment
2a. Where an authorisation is granted for national security or defence purposes, the obligation to make information publicly available shall not require the disclosure of classified information or other sensitive information where such disclosure would undermine national security or defence interests.

Or. en

Justification

Armed forces may need urgent access to essential devices for deployment or crisis response where no MDR-compliant device is available in time. Adds national security/defence as a derogation ground, protects classified information from publication, and enables EU-wide extension for multinational operations.

Amendment 528

Andreas Glück, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point d

Regulation (EU) 2017/745

Article 59 – paragraph 3

Text proposed by the CommissionAmendment
3. Where a request pursuant to paragraph 1 or paragraph 1a has been submitted to competent authorities in more than one Member State and based on an opinion of an expert panel referred to in Article 106, the Commission, in exceptional cases relating to public health, patient safety or patient health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 or paragraph 1a to the territory of the Union, or provide an authorisation referred to in paragraph 1 or paragraph 1a for the territory of the Union. The Commission may set out the conditions under which the device may be placed on the market or put into service, or under which the diagnostic or therapeutic service may be provided. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).;3. Where a request pursuant to paragraph 1 or paragraph 1a has been submitted to competent authorities in more than one Member State and based on an opinion of an expert panel referred to in Article 106, the Commission, in exceptional cases relating to public health, patient safety or patient health, or, where necessary for national security or defence purposes, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 or paragraph 1a to the territory of the Union, or provide an authorisation referred to in paragraph 1 or paragraph 1a for the territory of the Union. The Commission may set out the conditions under which the device may be placed on the market or put into service, or under which the diagnostic or therapeutic service may be provided. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).;

Or. en

Justification

Armed forces may need urgent access to essential devices for deployment or crisis response where no MDR-compliant device is available in time. Adds national security/defence as a derogation ground, protects classified information from publication, and enables EU-wide extension for multinational operations.

Amendment 529

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 49 – point e

Regulation (EU) 2017/745

Article 59 – paragraph 4

Text proposed by the CommissionAmendment
In the event of 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*****, the Commission may, by means of implementing acts, on its own initiative after consulting the MDCG, authorise the placing on the market or putting into service of a device in accordance with paragraph 3. The authorisation shall cease to apply at the latest when the recognition of the public health emergency is terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).In the event of 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*****, the Commission may, by means of implementing acts, on its own initiative after consulting the MDCG, authorise the placing on the market or putting into service of a device in accordance with paragraph 3. The authorisation shall cease to apply at the latest when the recognition of the public health emergency is terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) and reserved for devices intended for the treatment or prevention of a serious or life-threatening disease or condition, which is directly related to the public health emergency. In the event of harm caused to professionals or patients whilst using a device authorised in this way, the Member State must advance the compensation to which the victims are entitled without waiting for a final determination of liability.’

Or. fr

Amendment 530

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
Member States, on their own initiative or upon a substantiated request by a manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII IX, X, XI, XIV or XV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.Member States, on their own initiative or upon a substantiated request by a manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII IX, X, XI, XIV or XV would not be appropriate in light of the innovative scientific or technological characteristics of the device or of an innovative regulatory approach. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.

Or. en

Amendment 531

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
Member States, on their own initiative or upon a substantiated request by a manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII IX, X, XI, XIV or XV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.Member States may establish on their own initiative one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII IX, X, XI, XIV or XV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.

Or. en

Amendment 532

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Member States may also establish regulatory sandboxes jointly with other Member States.deleted

Or. en

Amendment 533

Tiemo Wölken

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 or, where duly justified, 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. Any temporary adaptation or waiver pursuant to this Article shall not affect the fundamental requirements relating to the safety and performance of devices laid down in this Regulation and shall ensure a high level of protection of public health and patient safety.

Or. en

Amendment 534

Valentina Palmisano

on behalf of The Left Group

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 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 exact duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.

Or. en

Amendment 535

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

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

Justification

Requirements may be adapted but never "waived."

Amendment 536

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 3

Text proposed by the CommissionAmendment
3. A regulatory sandbox shall be set up only if the following conditions are met:3. A regulatory sandbox shall be set up only if all of the following conditions are met:

Or. en

Amendment 537

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 3 – point a

Text proposed by the CommissionAmendment
(a) the device is expected to address unmet medical needs or to provide a significant clinical benefit to patients or to the health system compared with similar existing alternatives or the state of the art;(a) the device is expected to address an unmet medical need or provides a significant clinical benefit to patients or to the health system compared with existing alternatives or the state of the art;

Or. en

Amendment 538

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 3 – point b

Text proposed by the CommissionAmendment
(b) the application of the requirements of this Regulation referred to in paragraph 1 would impede or significantly delay the development of the device and access by healthcare professionals or lay users to such device.(b) the application of the requirements of this Regulation referred to in paragraph 1 would impede the development of the device and access by healthcare professionals or lay users to such device.

Or. en

Amendment 539

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 3 – point ba (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

Justification

This reflects wording of the IVDR on performance studies, and setting this condition before allowing set-up of a regulatory sandbox should provide a baseline of quality of these sandboxes with regard to rights and well-being of its subjects.

Amendment 540

András Tivadar Kulja

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

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

Text proposed by the CommissionAmendment
(ba) it has been duly demonstrated that the evidence necessary for the certification of the device concerned cannot be appropriately generated through the standard regulatory pathways.

Or. en

Amendment 541

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

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

Text proposed by the CommissionAmendment
(ba) Assigning the device to a regulatory sandbox would not result in additional risks when compared to the standard regulatory procedure outlined in this Regulation.

Or. en

Justification

The Commission proposal does not provide adequate safeguards for the regulatory sandboxes framework.

Amendment 542

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 5

Text proposed by the CommissionAmendment
5. Any participant in the regulatory sandbox shall, without undue delay, inform the competent authority that is responsible for the supervision of the regulatory sandbox about any harm occurred in relation to the implementation of the regulatory sandbox. The competent authority shall take immediate and adequate corrective measures, including to suspend, revoke or restrict the scope of the regulatory sandbox.5. ​Any participant in the regulatory sandbox shall, without undue delay, inform the competent authority that is responsible for the supervision of the regulatory sandbox about any incident, serious incident or other event that may adversely affect the safety, health or rights of patients, users or other persons in relation to the implementation of the regulatory sandbox. The competent authority shall take immediate and adequate corrective measures, including to suspend, revoke or restrict the scope of the regulatory sandbox.

Or. en

Amendment 543

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59b – paragraph 6

Text proposed by the CommissionAmendment
6. Manufacturers and prospective manufacturers participating in a regulatory sandbox shall remain liable under applicable Union and national law for any damage inflicted on third parties as a result of their activities taking place in the regulatory sandbox.6. Participation in a regulatory sandbox shall not affect the liability of participants under applicable Union and national liability law. Participants, including manufacturers and prospective manufacturers, shall remain liable for any harm caused to third parties as a result of activities carried out within the regulatory sandbox.

Or. en

Amendment 544

Valentina Palmisano

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 as soon as it intends to establish it and provide regular updates about its implementation and outcome. The Commission and MDCG should ensure coordination among Member States’ regulatory sandboxes to avoid duplications and integrate relevant outcomes of the regulatory sandbox into specific regulatory guidance or CS upon completion.

Or. en

Amendment 545

Tiemo Wölken

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, implementation and outcome of the regulatory sandbox. The Commission and the MDCG may use the experience gained to support the development of guidance or to assess whether adaptations to the Union regulatory framework are appropriate.

Or. en

Amendment 546

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission, on its own initiative or upon a substantiated request by a Member State, may establish, by means of implementing acts for a limited time and pursuant to a specific plan, Union regulatory sandboxes, which shall inform whether the existing requirements appropriately regulate a specific type of device with particular characteristics or emerging technologies, and there is a risk that the existing requirements:The Commission, on its own initiative or upon a substantiated request by a Member State, may establish, by means of implementing acts for a limited time and pursuant to a specific plan, Union regulatory sandboxes, which shall inform whether the existing requirements appropriately regulate a specific type of device with particular characteristics or emerging technologies.

Or. en

Amendment 547

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) would impede or significantly delay the development of such devices and access by healthcare professionals or lay users to those devices; ordeleted

Or. en

Amendment 548

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 1 – point b

Text proposed by the CommissionAmendment
(b) would not adequately protect the health and safety of patients, users or other persons or other aspects of public health.deleted

Or. en

Amendment 549

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation.Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation and they shall comply with the requirements for setting up regulatory sandboxes set out in article 59b, paragraph 3

Or. en

Amendment 550

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation.Union regulatory sandboxes shall not permit the placing on the market or putting into service of devices which do not comply with this Regulation.

Or. en

Amendment 551

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 3

Text proposed by the CommissionAmendment
3. The Commission shall inform the MDCG about the establishment of a regulatory sandbox and keep it informed about its outcome.3. The Commission shall keep the MDCG informed about the establishment, implementation and outcome of each Union regulatory sandbox.

Or. en

Amendment 552

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may, by means of implementing acts, specify common principles or the detailed arrangements for the establishment, operation and supervision of regulatory sandboxes pursuant to Article 59b or of Union regulatory sandboxes pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).4. The Commission may, by means of implementing acts, specify common principles or the detailed arrangements for the establishment, operation, supervision and evaluation of regulatory sandboxes pursuant to Article 59b or of Union regulatory sandboxes pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Or. en

Amendment 553

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 5

Text proposed by the CommissionAmendment
5. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this Article or Article 59b in order to adapt it to scientific, technical or regulatory progress and to take into account developments regarding regulatory sandboxes, including in areas other than medical devices.;5. ​The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this Article or Article 59b in order to adapt it to scientific, technical or regulatory progress and to take into account the experience gained from their implementation. regarding regulatory sandboxes.

Or. en

Amendment 554

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 50

Regulation (EU) 2017/745

Article 59c – paragraph 5a (new)

Text proposed by the CommissionAmendment
5a. The establishment and operation of a Union regulatory sandbox shall not affect the protection of public health or the fundamental requirements relating to the safety and performance of devices laid down in this Regulation.

Or. en

Amendment 555

Tiemo Wölken

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 59ca (new)

Text proposed by the CommissionAmendment
(50a) The following Article is inserted:
"
Article 59d
Annual reporting on regulatory sandboxes
The Commission, with input from the Member States and, where relevant, the expert panels referred to in Article 106, as well as the MDCG, shall submit an annual report to the European Parliament and the Council on the implementation of the regulatory sandboxes established in accordance with Articles 59b and 59c. The report shall include, where appropriate, information on the number of regulatory sandboxes established, trends regarding the categories of medical devices participating in regulatory sandboxes, good practices, difficulties encountered, lessons learnt, reflections on possible future adaptations of the regulatory framework, and recommendations concerning the establishment and operation of regulatory sandboxes and, where relevant, the application of this Regulation and other Union legal acts supervised within the regulatory sandboxes. The Commission shall make those reports, together with lay summaries thereof, publicly available.
"

Or. en

Amendment 556

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 59 ca (new)

Text proposed by the CommissionAmendment
(50a) The following article 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 an annual report with a breakdown on the number of sandboxes granted, and detailed information on their implementation and outcomes.

Or. en

Amendment 557

Tiemo Wölken

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 59cb (new)

Text proposed by the CommissionAmendment
(50b) The following Article is inserted:
"
Article 59e
Sandbox Plan
1. Prior to the establishment of a regulatory sandbox, the competent authority of the Member State or, in the case of a Union regulatory sandbox, the Commission shall adopt a sandbox plan. The sandbox plan shall define the objectives, scope, duration, governance and participants of the regulatory sandbox, specify the applicable regulatory requirements and, where appropriate, any temporary regulatory flexibilities, establish appropriate safeguards to ensure a high level of protection of public health and patient safety, and lay down arrangements for monitoring, reporting and evaluating the regulatory sandbox. The sandbox plan shall:
(a) identify the participants in the regulatory sandbox and their respective roles;
(b) define the objectives and scope of the regulatory sandbox;
(c) identify the provisions of this Regulation from which temporary derogations are considered necessary for the purposes of the regulatory sandbox, together with the corresponding safeguards;
(d) establish appropriate measures to ensure a high level of protection of public health, patient safety and the rights of participants;
(e) specify the duration of the regulatory sandbox and the conditions for its completion or early termination;
(f) establish the monitoring, reporting and evaluation arrangements applicable to the regulatory sandbox.
2. Before approving a sandbox plan, the competent authority of the Member State or, in the case of a Union regulatory sandbox, the Commission shall consult the MDCG where the regulatory sandbox is likely to have relevance beyond a single Member State or where a coordinated approach would facilitate the consistent application of this Regulation throughout the Union. Where appropriate, notified bodies, patient organisations, healthcare professionals and other relevant stakeholders shall also be consulted.
3. The Commission shall, after consulting the MDCG, adopt implementing acts laying down a common template and minimum requirements for sandbox plans, including the information to be provided regarding objectives, participants, risk mitigation measures, monitoring, reporting and evaluation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
4. Upon completion of a regulatory sandbox, the competent authority responsible for the national regulatory sandbox or, in the case of a Union regulatory sandbox, the Commission shall submit the sandbox plan and the final evaluation report to the MDCG. The MDCG shall take the results of completed regulatory sandboxes into account when developing guidance and recommendations under this Regulation.
"

Or. en

Amendment 558

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point a

Regulation (EU) 2017/745

Article 61 – paragraph 1

Text proposed by the CommissionAmendment
The manufacturer shall specify and justify the level of clinical evidence necessary to confirm the safety and performance of the device. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose, taking into consideration paragraph 10.The manufacturer shall conduct the clincial evaluation with the aim to establish the clinical evidence. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose, taking into consideration paragraph 10.

Or. en

Amendment 559

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point a

Regulations (EU) 2017/745

Article 61 – paragraph 2

Text proposed by the CommissionAmendment
2. For class IIb and class III devices, a manufacturer may, prior to its clinical investigation or clinical evaluation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy or proposals for clinical investigation. The manufacturer and the notified body involved in any future conformity assessment procedure shall, in the clinical evaluation report and the clinical evaluation assessment report, give due consideration to the advice of the expert panel and where they do not follow the advice, they shall provide duly justified reasons.;2. For class IIb and class III devices, a device manufacturer and the sponsor of the clinical trial(s) may, prior to its clinical investigation or clinical evaluation, consult an expert panel as referred to in Article 106, with the aim of reviewing the combined study’s intended clinical development strategy or proposals for clinical investigation. Notified Bodies should be able to participate. The device manufacturer and sponsor of the clinical trial(s) and the notified body involved in any future conformity assessment procedure shall, in the clinical evaluation report and the clinical evaluation assessment report, give due consideration to the advice of the expert panel and where they do not follow the advice, they shall provide duly justified reasons. They may ask expert panels to clarify the opinion it has provided.

Or. en

Amendment 560

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
(c) paragraph 5 is replaced by the following:deleted
‘5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.;’

Or. en

Justification

Maintain existing rules for equivalence, as clinical evidence through this route has been found insufficient, and so equivalence should not be made more flexible.

Amendment 561

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
(c) paragraph 5 is replaced by the following:deleted
‘5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.;’

Or. en

Amendment 562

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
(c) paragraph 5 is replaced by the following:deleted
‘5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.;’

Or. en

Amendment 563

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.;deleted

Or. en

Amendment 564

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.’;5. With the exception of class III, IIb and IIa devices where such devices integrate new components, a manufacturer of a device demonstrated to be equivalent, in terms of performance and safety, to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer requesting equivalence provides clear evidence thereof to the notified body.’;

Or. fr

Amendment 565

Ondřej Dostál

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point c

Regulation (EU) 2017/745

Article 61 – paragraph 5

Text proposed by the CommissionAmendment
5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.;5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body;

Or. en

Justification

Amendment 92 amounts to excessive burden for manufacturers.

Amendment 566

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

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point d – point ii

Regulation (EU) 2017/745

Article 61 – paragraph 6 – point b

Text proposed by the CommissionAmendment
(b) that are well-established technology devices for which the clinical evaluation is based on sufficient clinical evidence and is in compliance with the relevant product-specific CS, where such CS are available.’;(b) that are well-established technology devices for which the clinical evaluation is based on sufficient clinical evidence and is in compliance with the relevant product-specific CS, where such CS are available.’; The notified body shall not require a new clinical investigation where the available clinical data are sufficient to demonstrate conformity with the applicable general safety and performance requirements.’;

Or. fr

Amendment 567

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

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point f

Regulation (EU) 2017/745

Article 61 – paragraph 10

Text proposed by the CommissionAmendment
10. Without prejudice to paragraph 4, where the confirmation of safety and performance based on clinical data is not deemed appropriate, adequate justification shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer and the data available for the generic device group. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modeling or simulation and pre-clinical evaluation, to be adequate.10. Without prejudice to paragraph 4, where the confirmation of safety and performance based on clinical data is not deemed appropriate, adequate justification shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer and the data available for the generic device group. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on appropriate evidence, including, where relevant, scientific literature, post-marketing surveillance data, post-marketing clinical follow-up, real-world data and the results of non-clinical testing methods alone, including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modeling or simulation and pre-clinical evaluation, or a combination thereof, to be adequate.

Or. fr

Amendment 568

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point f

Regulation (EU) 2017/745

Article 61 – paragraph 10

Text proposed by the CommissionAmendment
10. Without prejudice to paragraph 4, where the confirmation of safety and performance based on clinical data is not deemed appropriate, adequate justification shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer and the data available for the generic device group. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modeling or simulation and pre-clinical evaluation, to be adequate.10. Without prejudice to paragraph 4, where the confirmation of safety and performance based on clinical data is not deemed appropriate, adequate justification shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer and the data available for the generic device group. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, real-world data, computational modeling or simulation and pre-clinical evaluation, to be adequate.

Or. en

Amendment 569

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point f

Regulation (EU) 2017/745

Article 61 – paragraph 10

Text proposed by the CommissionAmendment
11. The clinical evaluation, its documentation and, where applicable and needed, the summary of safety and performance referred to in Article 32 shall be updated throughout the life cycle of the device concerned with data and findings obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84, whenever those data and findings obtained from PMCF provide information relevant for the confirmation of safety and performance of the device.’11. The clinical evaluation, its documentation and, where applicable and needed, the summary of safety and performance referred to in Article 32 shall be updated throughout the life cycle of the device concerned with data and findings obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84, whenever those data and findings obtained from PMCF provide information relevant for the confirmation of safety and performance of the device.’
For Class III devices and implantable devices, the PMCF assessment report shall be updated whenever there is essential information concerning the safety and performance of the device that is relevant to the healthcare professional, the patient or the user. The summary of safety and clinical performance referred to in Article 32 shall be updated with new data only where necessary to ensure that any clinical and/or safety information contained in the SSCP remains accurate and complete.

Or. it

Justification

This amendment makes PMCF and SSCP updates more proportionate by making them conditional on the presence of new relevant information on the safety or performance of the device. It thus prevents low-value routine updates, reduces administrative burden, and enables manufacturers, notified bodies and authorities to focus on evidence and changes that truly affect patient safety.

Amendment 570

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point f

Regulation (EU) 2017/745

Article 61 – paragraph 11

Text proposed by the CommissionAmendment
11. The clinical evaluation, its documentation and, where applicable and needed, the summary of safety and performance referred to in Article 32 shall be updated throughout the life cycle of the device concerned with data and findings obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84, whenever those data and findings obtained from PMCF provide information relevant for the confirmation of safety and performance of the device.11. The clinical evaluation, its documentation and, where applicable and needed, the summary of safety and performance referred to in Article 32 shall be updated throughout the life cycle of the device concerned with data and findings obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post market surveillance plan referred to in Article 84, whenever those data and findings obtained from PMCF demonstrate that there is a significant change in the benefit-risk determination.

Or. en

Amendment 571

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point h

Regulation (EU) 2017/745

Article 61 – paragraph 14

Text proposed by the CommissionAmendment
14. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annex XIV in order to adapt it to technical and scientific progress and developments at international level, having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health.’;deleted

Or. fr

Amendment 572

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

Proposal for a regulation

Article 1 – paragraph 1 – point 52 – point h

Regulation (EU) 2017/745

Article 61 – paragraph 14

Text proposed by the CommissionAmendment
14. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annex XIV in order to adapt it to technical and scientific progress and developments at international level, having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health.’;14. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annex XIV in order to adapt it to technical and scientific progress and developments at international level, having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health.’;
In the case of devices for which an expert panel referred to in Article 106 has issued an opinion confirming compliance with the criteria for a breakthrough device as referred to in Article 52a(2), the manufacturer of another device may not invoke equivalence with the breakthrough device to confirm the safety and performance of its device until 10 years have passed since the breakthrough device was first placed on the market, unless the manufacturer has obtained the prior written consent of the manufacturer of the breakthrough device or the latter no longer supplies the European market.

Or. fr

Amendment 573

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 53 a (new)

Regulation (EU) 2017/745

Article 63 – paragraph 2 – point a – points (ii), (iii) and (iv)

Present textAmendment
(53a) In Article 63 paragraph 2 point (a), points (ii), (iii) and (iv) shall be replaced by the following:
(ii) the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification;"(ii) the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification; Where informed consent has been given via electronic systems, it shall be ensured that subjects have the right to withdraw consent at any time through an easy-to-use and user-friendly electronic system.
(iii) the conditions under which the clinical investigation is to be conducted, including the expected duration of the subject's participation in the clinical investigation and arrangements for reimbursements of expenses and compensation in regard to occurring costs for the subject;
(iv) the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued either by the subject itself or by the discontinuation of the investigation by the clinical trials sponsor;"

Or. en

(Regulation (EU) 2017/745)

Amendment 574

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 53 b (new)

Regulation (EU) 2017/745

Article 63 – paragraph 3a (new)

Present textAmendment
(53b) In Article 63, the following paragraph 3a (new) is added:
Article 63 - Informed consent"The communication in the context of an interview between the investigator and the subject or the investigator and the subject and its legally designated representative, as applicable, may be done remotely through use of electronic means. The record of the informed consent procedure may have an electronic form, which shall be regularly updated, where necessary, to reflect the continuous and evolving nature of informed consent and shall be signed relying on electronic identification means complying with Regulation (EU) No 910/2014 of the European Parliament and of the Council* or the equivalent standards."

Or. en

(Regulation (EU) 2017/745)

Amendment 575

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 53 c (new)

Regulation (EU) 2017/745

Article 63 – paragraph 2 – point ea (new)

Text proposed by the CommissionAmendment
(53c) in Article 63, paragraph 2, the following point ea (new) is added:
"
include the post trial provisions, including where appropriate arrangements for continued access to arrangements to an intervention as identified as beneficial and reasonably safe during the clinical trial;
"

Or. en

Amendment 576

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 55

Regulation (EU) 2017/745

Article 65 – point g

Text proposed by the CommissionAmendment
(ii) a benefit for the population represented by the minor subject provided that the clinical investigation will pose only minimal risk to, and will impose minimal burden on, the minor subject in comparison with the standard treatment of the subject's condition.’;(ii) a benefit for the population represented by the minor subject provided that the clinical investigation will pose only minimal risk to, and will impose minimal burden on, the minor subject in comparison with the standard treatment of the subject's condition.’; however, clinical trials relating to gender transitions are expressly excluded from the scope of clinical investigations involving minors,’;

Or. fr

Amendment 577

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 58

Regulation (EU) 2017/745

Point 58 – article 72 – paragraph 7

Text proposed by the CommissionAmendment
7. The processing of personal data in the context of a clinical investigation, including the secondary use of personal data initially collected for other investigations, shall be deemed to be carried out for scientific research purposes as referred to in Article 9(2), point (j), of Regulation (EU) 2016/679.;7. The processing of personal data in the context of a clinical investigation, including the secondary use of personal data initially collected for other investigations, shall be deemed to be carried out for scientific research purposes as referred to in Article 9(2), point (j), of Regulation (EU) 2016/679, subject to compliance with that Regulation. Participants in the clinical investigation shall be informed thereof, including the possibility of such secondary use, as part of the informed consent process.

Or. en

Amendment 578

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 58

Regulation (EU) 2017/745

Article 72 – paragraph 7

Text proposed by the CommissionAmendment
7. The processing of personal data in the context of a clinical investigation, including the secondary use of personal data initially collected for other investigations, shall be deemed to be carried out for scientific research purposes as referred to in Article 9(2), point (j), of Regulation (EU) 2016/679.;7. The processing of personal data in the context of a clinical investigation, including the secondary use of personal data initially collected for other investigations, shall be deemed to be carried out for scientific research purposes as referred to in Article 9(2), point (j), of Regulation (EU) 2016/679. Participants in the clinical investigation shall be informed thereof, including the possibility of such secondary use, as part of the informed consent process.;

Or. en

Amendment 579

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

Proposal for a regulation

Article 1 – paragraph 1 – point 61 – point b

Regulation (EU) 2017/745

Article 78 – paragraph 5

Text proposed by the CommissionAmendment
5. Each Member State concerned may request, on a single occasion, additional information from the sponsor. The sponsor shall submit the requested additional information within 12 days of receipt of the request. The expiry of the last deadline pursuant to paragraph 4, point (d), shall be suspended from the date of the request until such time as the additional information has been received.’;5. Each Member State concerned may request, on a single occasion, additional information from the sponsor. The sponsor shall submit the requested additional information within 12 days of receipt of the request. The expiry of the last deadline pursuant to paragraph 4, point (d), shall be suspended from the date of the request until such time as the additional information has been received. The information requested must be strictly limited to what is necessary.’;

Or. fr

Amendment 580

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 61 – point b a (new)

Regulation (EU) 2017/745

Article 78 – paragraph 5a (new)

Text proposed by the CommissionAmendment
(ba) in Article 78, the following paragraph 5a is added:
The processing of personal data within the post-market surveillance system, including the secondary use of personal data initially collected during the real world use of a medical device, shall be considered as processing for scientific research purposes within the meaning of Article 9(2), point (j), of Regulation (EU) 2016/679.;

Or. en

Amendment 581

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

Proposal for a regulation

Article 1 – paragraph 1 – point 64 a (new)

Regulation (EU) 2017/745

Article 82 – paragraph 2a (new)

Text proposed by the CommissionAmendment
(64a) Clinical investigation data generated outside the scope of this Chapter may be relied upon by a manufacturer for the purpose of demonstrating conformity with this Regulation only where the manufacturer demonstrates that those data were generated in accordance with requirements ensuring a level of protection of subjects, scientific validity and data integrity equivalent to those laid down in this Chapter. Compliance with those requirements shall be subject to verification by the competent authorities and, where applicable, by the notified body.

Or. en

Amendment 582

Valentina Palmisano

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 86 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects. The PSUR shall be part of the technical documentation as specified in Annex III.Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination, or in the acceptability of undesirable side-effects, or when otherwise necessary, including but not limited to changes in the frequency or severity of incidents or side effects, following the occurrence of a serious incident or identification of a new safety signal, following the implementation of a field safety corrective action, or when new clinical or performance data becomes available that may impact the evaluation of safety or performance. The PSUR shall be part of the technical documentation as specified in Annex III.

Or. en

Amendment 583

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 86 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects. The PSUR shall be part of the technical documentation as specified in Annex III.Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects, or when otherwise necessary, including but not limited to changes in the frequency or severity of incidents or side effects, following the occurrence of a serious incident or identification of a new safety signal, following the implementation of a field safety corrective action, or when new clinical or performance data becomes available that may impact the evaluation of safety or performance. The PSUR shall be part of the technical documentation as specified in Annex III.

Or. en

Amendment 584

Tiemo Wölken

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 86 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects. The PSUR shall be part of the technical documentation as specified in Annex III.Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects. Where the notified body has limited the validity of a certificate in accordance with Article 56(3), the PSUR shall be updated annually for the duration of that period of limited validity in order to support the assessment of compliance with the conditions attached to the certificate. The PSUR shall be part of the technical documentation as specified in Annex III.

Or. en

Amendment 585

Ruggero Razza, Michele Picaro

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 86 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Manufacturers of class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects. The PSUR shall be part of the technical documentation as specified in Annex III.Manufacturers of implantable class IIb and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter and when there is a significant change in the benefit-risk determination or in the acceptability of undesirable side-effects. The PSUR shall be part of the technical documentation as specified in Annex III.

Or. it

Justification

This amendment introduces a more proportionate and risk-based approach to the PSUR obligations for class IIb non-implantable devices. Following an initial update within two years of certification, further updates to the PSUR would only be required if justified by changes to the risk-benefit profile of the device or to the acceptability of the side effects. This reduces unnecessary burden while maintaining robust supervision for higher-risk devices.

Amendment 586

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

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 at least once in the first two years after the certificate is issued, and when necessary thereafter, including but not limited to when there is a significant change in the benefit-risk determination, in the frequency or severity of incidents or side effects, following the occurrence of a serious incident or identification of a new safety signal, following the implementation of a field safety corrective action, or when new clinical or performance data becomes available that may impact the evaluation of safety or performance of the device.. The PSURs shall be part of the technical documentation specified in Annex III. ;

Or. en

Justification

There should be clearer frequency of updating the PSUR.

Amendment 587

Valentina Palmisano

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 at least once in the first two years after the certificate is issued and when necessary, e.g. when there is a significant change in the benefit-risk determination, in the frequency or severity of incidents or side effects, following the occurrence of a serious incident or identification of a new safety signal, following the implementation of a field safety corrective action, or when new clinical or performance data becomes available that may impact the evaluation of safety or performance of the device. The PSURs shall be part of the technical documentation specified in Annex III.

Or. en

Amendment 588

Ruggero Razza, Michele Picaro

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 non-implantable class IIa and class IIb devices shall update the PSUR at least once within two years following the issuance of the certificate and when necessary on the basis of a significant change in the benefit-risk balance or in the acceptability of undesirable side-effects. The PSURs shall be part of the technical documentation specified in Annex III.

Or. it

Justification

This amendment introduces a more proportionate and risk-based approach to the PSUR obligations for class IIb non-implantable devices. Following an initial update within two years of certification, further updates to the PSUR would only be required if justified by changes to the risk-benefit profile of the device or to the acceptability of the side effects. This reduces unnecessary burden while maintaining robust supervision for higher-risk devices.

Amendment 589

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 67 – point b

Regulation (EU) 2017/745

Article 86 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. 2a. For class IIb and class III devices, other than custom-made, investigational and well-established technology devices, the manufacturer shall make publicly available through Eudamed, in a structured format, a summary of the main findings of each periodic safety update report referred to in paragraph 1.
The summary shall be published no later than 30 days after finalisation of the PSUR and, in any event, no later than 120 days after the end of the reporting period to which the PSUR relates. Where review by a notified body is required pursuant to paragraph 2 and has not been completed before publication, the summary shall indicate that the notified body review is pending and shall be updated, where necessary, no later than 30 days after completion of that review.
The Commission shall, by means of implementing acts, specify the format and minimum content of the summary. The minimum content shall include:
(a) any safety or performance concerns identified during the reporting period;
(b) a description of any corrective or preventive actions taken and their outcomes;
(c) the main findings of post-market clinical follow-up conducted during the reporting period; and
(d) the manufacturer's conclusion on whether the benefit-risk profile of the device remains acceptable.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Or. en

Amendment 590

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

Proposal for a regulation

Article 1 – paragraph 1 – point 68 – point a – point -i (new)

Regulation (EU) 2017/745

Article 87 – paragraph 1 – subparagraph 1 – introductory text

Text proposed by the CommissionAmendment
– in the first subparagraph, the introductory wording is replaced by the following:
‘
1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report to the authority responsible for the notified body which issued the certificate, in accordance with Articles 92(5) and (7), the following:
’

Or. fr

Amendment 591

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 1 – paragraph 1 – point 68 – point b

Regulation (EU) 2017/745

Article 87 – paragraph 3

Text proposed by the CommissionAmendment
3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 30 days after they become aware of the incident.;3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.;

Or. en

Justification

To reflect current standards

Amendment 592

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 68 – point b

Regulation (EU) 2017/745

Article 87 – paragraph 3

Text proposed by the CommissionAmendment
3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 30 days after they become aware of the incident.’;3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.’;

Or. fr

Amendment 593

Kateřina Konečná

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 87 – paragraph 10

Text proposed by the CommissionAmendment
(ba) In Article 87, paragraph 10 is replaced by the following:
‘
10. Member States shall ensure that clear, accessible, and user-friendly channels are available through which patients, carers, healthcare professionals and other users may directly report suspected serious incidents and device deficiencies to the competent authorities, independently of the manufacturer's reporting systems.
Member States shall ensure that competent authorities have sufficient capacity and procedures to receive, analyse and follow up on such reports in a timely manner, and to coordinate with competent authorities of other Member States and with the European Medicines Agency where signals require cross-border action.
Competent authorities shall publish, on an annual basis, aggregate statistics on reports received from patients, carers, users and healthcare professionals.
The Commission may, by means of implementing acts, specify harmonised reporting formats and interoperable digital interfaces to be supported through the electronic system referred to in Article 92. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
’

Or. en

Amendment 594

Tiemo Wölken

Proposal for a regulation

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

Regulation (EU) 2017/745

Article 87 – paragraph 10

Present textAmendment
(68a) In Article 87, paragraph 10 is replaced by the following:
10. The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1. The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients."10. The Member States shall take appropriate measures, including targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1.
To that end, Member States shall ensure the availability of clear, accessible and user-friendly reporting channels enabling patients, carers, healthcare professionals and other users to report directly to the competent authorities suspected serious incidents and device deficiencies, independently of the manufacturer's reporting systems.
The competent authorities shall centrally record at national level all reports received from healthcare professionals, users, patients, carers and other users. Member States shall ensure that competent authorities have adequate resources and procedures to receive, assess, investigate and follow up on such reports in a timely manner and, where appropriate, to coordinate with the competent authorities of other Member States and with the European Medicines Agency where the reports or resulting signals require cross-border action.
Competent authorities shall publish, at regular intervals, aggregated and anonymised statistics on reports received from healthcare professionals, users, patients, carers and other users.
The Commission may, by means of implementing acts, lay down harmonised requirements concerning reporting frequency, reporting formats and interoperable digital interfaces to be supported through the electronic system referred to in Article 92. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3)."

Or. en

(Regulation (EU) 2017/745)

Amendment 595

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 69

Regulation (EU) 2017/745

Article 87a

Text proposed by the CommissionAmendment
(69) the following Article 87a is inserted:deleted
‘Article 87a
Reporting of actively exploited vulnerabilities and severe incidents related to devices
1. Without prejudice to the reporting obligations regarding serious incidents and field safety corrective actions set out in Article 87, the manufacturer of a device shall report to the computer security incident response teams (‘CSIRTs’), designated as coordinators of the Member States where a device has been made available, and to the European Union Agency for Cybersecurity (ENISA), either of the following:
(a) any actively exploited vulnerability as defined in Article 3, point (42), of Regulation (EU) 2024/2847 of the European Parliament and of the Council******* contained in the device;
(b) any severe incident as referred in Article 14(5) of Regulation (EU) 2024/2847 having an impact on the security of the device.
2. The manufacturer shall submit the report referred to in paragraph 1 through the electronic system referred to in Article 92 not later than 30 days after it becomes aware of the actively exploited vulnerability or the severe incident.
3. The report referred to in paragraph 1, as well as any report submitted by a manufacturer in accordance with Article 87 that also qualifies as actively exploited vulnerability or severe incident, shall be made available simultaneously to the CSIRTs designated as coordinators of the Member States in which the device has been made available and to ENISA.
4.
For the purposes of this Article, the CSIRTs designated as coordinators and ENISA shall have access to Eudamed.’
******* Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L, 2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj).;’

Or. en

Amendment 596

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

Proposal for a regulation

Article 1 – paragraph 1 – point 69

Regulation (EU) 2017/745

Article 87 a – paragraph 2

Text proposed by the CommissionAmendment
2. The manufacturer shall submit the report referred to in paragraph 1 through the electronic system referred to in Article 92 not later than 30 days after it becomes aware of the actively exploited vulnerability or the severe incident.2. The manufacturer shall submit the report referred to in paragraph 1 through the electronic system referred to in Article 92 without delay, and not later than 30 days after it becomes aware of the actively exploited vulnerability or the severe incident.

Or. fr

Amendment 597

Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 69 a (new)

Regulation (EU) 2017/745

Article 87a new

Text proposed by the CommissionAmendment
(69a) the following Article 87a is inserted:
‘
Article 87a
Reporting of cybersecurity incidents and coordinated vulnerability disclosure
1. The manufacturer of a device shall consider:
(a) any actively exploited vulnerability as defined in Article 3, point (42), of Regulation (EU) 2024/2847 of the European Parliament and of the Council contained in the device;
(b) any severe incident as referred in Article 14(5) of Regulation (EU) 2024/2847 having an impact on the security of the device as serious incident which shall be proceeded according to Article 87 and 89.
2. The manufacturer shall submit initial report of serious incident referred to in paragraph 1 through the electronic system referred to in Article 92 without undue delay and in any event within 24 hours of the manufacturer becoming aware of it, to the competent authority and to the computer security incident response teams (‘CSIRTs’), designated as coordinators of the Member States where a device has been made available and to ENISA.
3. Competent authorities shall cooperate with computer security incident response teams (‘CSIRTs’), designated as coordinators of the Member States where a device has been made available, when resolving serious incidents referred to in paragraph 1. The cooperation shall include exchange of all information in reference to reported exploited vulnerability or severe incident between competent authority, CSIRT and ENISA.
4. For the purposes of this Article, the CSIRTs designated as coordinators and ENISA shall have access to Eudamed.
5. CSIRTs may act as coordinator for the purpose of coordinated vulnerability disclosure for devices as set out in Article 12 of Directive (EU) 2022/2555 and shall cooperate with competent authority.
’

Or. en

Justification

Both kinds of incidents referred to in article 87a paragraph 1 in the CRA are considered triggering immediate notification and having serious impact. We should keep the analogous perspective. The early warning in article 87a paragraph 2 aligns the provisions with CRA. Furthermore, if we try to match reporting exploited vulnerabilities and severe incidents as defined in CRA we should look into timelines which refer to serious public health threat, because it is a scale relevant to a risk connected to them. The vulnerability or severe incident not always is connected with risk of death or serious illness. That’s why the provisions of MDR/IVDR have to specify that. Risk caused by vulnerability in the software influence the same moment to every user of the device and it may be really significant amount of people. So if we adjust timelines to MDR/IVDR timelines, the deadline for serious public health threat would be the most relevant. Furthermore, it has to be clearly specified that CSIRT and CA are able to cooperate without limitation in reference to exchange of information. Such data are sensitive and have to be protected, but in reference to MD this exchange is needed because of safety of patients and users. It is necessary to cover a gap in NIS2 directive, which relates CVD (coordinated vulnerability disclosure) to ICT products.

Amendment 598

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 71 – point b

Regulation (EU) 2017/745

Article 89 – paragraph 2

Text proposed by the CommissionAmendment
2. Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 87 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer.;2. Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 87 is evaluated centrally at national level without undue delay by their competent authority, if possible together with the manufacturer;

Or. en

Amendment 599

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 74 – point c

Regulation (EU) 2017/745

Article 93 – paragraph 2

Text proposed by the CommissionAmendment
2. The competent authorities shall draw up annual surveillance activity plans, taking into account the European market surveillance programme, which shall be developed and maintained by the MDCG, and local circumstances.;2. The competent authorities shall draw up annual surveillance activity plans, taking into account the European market surveillance programme, which shall be developed and maintained by the MDCG, and take into account local circumstances.;

Or. en

Amendment 600

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

Proposal for a regulation

Article 1 – paragraph 1 – point 75

Regulation (EU) 2017/745

Article 94 – paragraph 2

Text proposed by the CommissionAmendment
The relevant economic operators and, where applicable and requested, the notified body that issued a certificate for the device in question shall cooperate with the competent authorities.The relevant economic operators and, where applicable and requested, the notified body that issued a certificate for the device in question shall cooperate with the competent authorities. Before concluding the assessment, the competent authorities shall report their preliminary conclusions to the economic operator concerned and give it the opportunity to submit observations or additional technical information, except where immediate action is necessary to remedy a significant risk to health or safety.’

Or. fr

Amendment 601

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 84 – point b

Regulation (EU) 2017/745

Article 103 – paragraph 7

Text proposed by the CommissionAmendment
7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organisations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to the MDCG and its sub-groups in the capacity of observers.;7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organisations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to participate in the work of the MDCG and its sub-groups as observers and shall be consulted, where relevant, on matters within their field of expertise. The MDCG shall ensure structured and regular engagement with those organizations so that their expertise and experience are appropriately taken into account in the performance of its tasks. The MDCG shall ensure a fair representation of healthcare professionals, patients and consumers covering a wide range of relevant experience and a broad geographical range.
The MDCG shall, where appropriate, cooperate and exchange information with the Coordination Group on Health Technology Assessment established pursuant to Article 3 of Regulation (EU) 2021/2282 on matters of common interest. Such cooperation shall facilitate the exchange of scientific and technical expertise, promote regulatory coherence, and avoid unnecessary duplication of work, while respecting the respective tasks and responsibilities of each body.

Or. en

Amendment 602

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 84 – point b

Regulation (EU) 2017/745

Article 103 – paragraph 7

Text proposed by the CommissionAmendment
7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organisations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to the MDCG and its sub-groups in the capacity of observers.;7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organisations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to the MDCG and its sub-groups in the capacity of observers.The MDCG shall establish a dedicated sub-group for representatives of patients and healthcare professionals to facilitate exchange of information and gather input on activities of relevance to these stakeholders, with appropriate remuneration of experts involved or their organisations;

Or. en

Amendment 603

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 84 – point b

Regulation (EU) 2017/745

Article 103 – paragraph 7

Text proposed by the CommissionAmendment
7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organisations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to the MDCG and its sub-groups in the capacity of observers.;7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organisations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to the MDCG and its sub-groups in the capacity of observers.The MDCG shall establish a dedicated sub-group for representatives of patients and healthcare professionals to facilitate exchange of information and gather input on activities of relevance to these stakeholders, with appropriate remuneration of experts involved or their organisations;

Or. en

Amendment 604

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 85

Regulation (EU) 2017/745

Article 104

Text proposed by the CommissionAmendment
(85) in Article 104, the second sentence is deleted;(85) Article 104 is amended as follow;
'
The Commission shall support the functioning of the cooperation between national competent authorities. It shall organise the meetings of the MDCG and its sub-groups, participate in those meetings and ensure their appropriate follow-up.
The Commission shall establish appropriate arrangements for the reimbursement of travel, accommodation and other necessary expenses incurred by representatives of organisations representing healthcare professionals, patients and consumers participating in the work of the MDCG and its sub-groups pursuant to Article 103, as well as in the work of the expert panels pursuant to Article 106. Where justified, those arrangements may also provide for appropriate remuneration for their contribution, in accordance with applicable Union rules.
'

Or. en

Amendment 605

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 105

Text proposed by the CommissionAmendment
In addition to the tasks assigned to it in other provisions of this Regulation and Regulation (EU) 2017/746, the MDCG shall in particular assist the Commission in the assessment of any issue related to the implementation of those Regulations and contribute to the development of guidance aimed at ensuring their effective and harmonised implementation.In addition to the tasks assigned to it in other provisions of this Regulation and Regulation (EU) 2017/746, the MDCG shall in particular assist the Commission in the assessment of any issue related to the implementation of those Regulations and contribute to the development of guidance aimed at ensuring their effective and harmonised implementation.
This shall include guidance documents for determining the validity period for certificates for high-risk devices, which may be dedicated to specific types of device, as appropriate.

Or. en

Justification

With the shift to open-ended certificates as a general rule, guidance should nevertheless clarify those cases where a finite period of validity is more appropriate for certain devices, based on expert opinion and evidence.

Amendment 606

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission shall, by means of implementing acts and following consultation with the MDCG, make provision for expert panels to be designated to provide scientific, clinical, technical or regulatory opinions and advice in relation to the implementation of this Regulation and of Regulation (EU) 2017/746 to the Commission, the MDCG, Member States, notified bodies or manufacturers.The Commission shall, by means of implementing acts and following consultation with the MDCG, make provision for expert panels to be designated to provide scientific, clinical, or technical opinions and advice in relation to the implementation of this Regulation and of Regulation (EU) 2017/746 to the Commission, the MDCG, Member States, notified bodies or manufacturers.

Or. en

Justification

Expert panels should provide scientific, clinical and technical advice — regulatory authority stays with Member States via the MDCG ('support', not independent tasks). Adding patient representatives with disease-area experience as full members increases legitimacy and real-world relevance, following the EMA model.

Amendment 607

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 2 – subparagraph 1

Text proposed by the CommissionAmendment
Expert panels shall consist of experts with proven up-to-date clinical, scientific, technical or regulatory expertise in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union.Expert panels shall consist of experts with proven up-to-date clinical, scientific, technical or regulatory expertise in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union. Expert panels shall include patient representatives from, for instance, patient organisations, with experience in the relevant disease area, ensuring balanced and meaningful participation alongside other experts.

Or. en

Justification

Expert panels should provide scientific, clinical and technical advice — regulatory authority stays with Member States via the MDCG ('support', not independent tasks). Adding patient representatives with disease-area experience as full members increases legitimacy and real-world relevance, following the EMA model.

Amendment 608

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 2

Text proposed by the CommissionAmendment
Expert panels shall consist of experts with proven up-to-date clinical, scientific, technical or regulatory expertise in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union.Expert panels shall consist of experts with proven up-to-date clinical, scientific, technical or regulatory expertise in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union. Experts panels may include patient representatives with experience in the relevant disease area, ensuring balanced and meaningful participation alongside other experts.

Or. en

Amendment 609

Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 2

Text proposed by the CommissionAmendment
Expert panels shall consist of experts with proven up-to-date clinical, scientific, technical or regulatory expertise in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union.Expert panels shall consist of experts with proven up-to-date clinical, scientific, technical or regulatory expertise in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union. Expert panels shall include patient representatives, ensuring balanced and meaningful participation alongside other experts.

Or. en

Amendment 610

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 2

Text proposed by the CommissionAmendment
Experts shall be appointed following publication of a call for expressions of interest. Depending on the type of task and the need for specific expertise, experts may be appointed to the panels for a maximum period of three years and their appointment may be renewed.Experts shall be appointed by the Commission following publication of a call for expressions of interest. Depending on the type of task and the need for specific expertise, experts may be appointed to the panels for a maximum period of three years and their appointment may be renewed.

Or. en

Amendment 611

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 4

Text proposed by the CommissionAmendment
4. Expert panels shall take into account relevant information provided by stakeholders including patients' organisations and healthcare professionals’ associations.4. Expert panels shall ensure structured engagement with stakeholders, including patients' organisations and healthcare professionals' associations. Where appropriate, they shall invite patient representatives with experience in the relevant disease area and healthcare professionals with relevant clinical expertise to contribute to their work, ensuring balanced and meaningful participation alongside other experts. The expert panels shall take due account of the information and views provided by those stakeholders in the performance of their tasks.

Or. en

Amendment 612

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 4

Text proposed by the CommissionAmendment
4. Expert panels shall take into account relevant information provided by stakeholders including patients' organisations and healthcare professionals’ associations.4. Expert panels shall take into account relevant information provided by stakeholders, including patients, carers, patient organisations and healthcare professional associations. Where the composition of the panel does not include the lived-experience expertise relevant to the device, condition or user population concerned, the panel shall seek such input before adopting its opinion or advice. The published opinion or advice shall indicate how such input has been taken into account .

Or. en

Amendment 613

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 4

Text proposed by the CommissionAmendment
4. Expert panels shall take into account relevant information provided by stakeholders including patients' organisations and healthcare professionals’ associations.4. Expert panels shall take into account relevant information provided by stakeholders, including patients, carers, patient organisations and healthcare professional associations. Where the composition of the panel does not include the lived-experience expertise relevant to the device, condition or user population concerned, the panel shall seek such input before adopting its opinion or advice.

Or. en

Amendment 614

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 5

Text proposed by the CommissionAmendment
5. Experts may be included on a list of available experts who, whilst not being formally appointed to a panel, are available to provide advice and to support the work of the expert panels as needed.5. Experts may be included on a list of available experts who, whilst not being formally appointed to a panel, are available to provide advice and to support the work of the expert panels as needed. That list shall include, where relevant to the remit of the expert panels, persons with lived experience and persons nominated by patient organisations with expertise relevant to the conditions, devices or groups of devices concerned. Expert panels shall, in addition, seek input from stakeholder organisations, including patient organisations and healthcare professional associations.
Declarations of interest requirements applicable to panel members and to listed experts shall be applied in a proportionate manner, ensuring impartiality and transparency while enabling the effective participation of persons with lived experience and patient organisations

Or. en

Amendment 615

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 5

Text proposed by the CommissionAmendment
5. Experts may be included on a list of available experts who, whilst not being formally appointed to a panel, are available to provide advice and to support the work of the expert panels as needed.5. Experts may be included on a list of available experts who, whilst not being formally appointed to a panel, are available to provide advice and to support the work of the expert panels as needed. That list shall include, where relevant to the remit of the expert panels, persons with lived experience and persons nominated by patient organisations with expertise relevant to the conditions, devices or groups of devices concerned. Expert panels shall, in addition, seek input from stakeholder organisations, including patient organisations and healthcare professional associations.

Or. en

Justification

Expert panels should provide scientific, clinical and technical advice — regulatory authority stays with Member States via the MDCG ('support', not independent tasks). Adding patient representatives with disease-area experience as full members increases legitimacy and real-world relevance, following the EMA model.