Text · Report parliamentary committee draft
On the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
Full title
On the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
Document SANT-PR-787987 · COM(2025)1023 – C10-0360/2025 – 2025/0404(COD)
- Kind
- Report parliamentary committee draft SANT-PR-787987
- Date
- 30 June 2026
- Committee
- Committee on Public Health
- Rapporteur
- Oliver Schenk
- Dossier
- 2025-0404
More facts (3)
- Formats
- Official page PDF Word
- Subject matter
- SANT, MARI, TECN
- Reference
- COM(2025)1023 – C10-0360/2025 – 2025/0404(COD)
In short
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The draft report is the rapporteur's first version of Parliament's position on a proposal to simplify the rules on medical devices and in vitro diagnostic medical devices. It keeps patient safety safeguards while reducing administrative burden, clarifying regulatory status and classification, and adapting rules for breakthrough, orphan and niche devices. It amends Regulation (EU) 2017/745 and Regulation (EU) 2017/746 on single-use devices, equivalence, combined studies, notified body timelines, expert panels, advertising, importer checks and electronic instructions for use. It also amends Regulation (EU) 2022/123 on the European Medicines Agency's support for expert panels and Regulation (EU) 2024/1689 on the list of Union harmonisation legislation in its Annex I.
Position. The rapporteur proposes to amend the Commission proposal to simplify the rules while preserving patient safety safeguards, clarifying regulatory status and classification, supporting breakthrough, orphan and niche devices, and making conformity assessment and notified body procedures more efficient and predictable.
Key points
- Simplification must safeguard a high level of patient protection and confidence in the safety and performance of devices, and must not weaken clinical evidence requirements.
- Software updates that do not alter intended purpose, clinical functionality or risk profile should not trigger a new full conformity assessment; healthcare professionals keep professional judgement.
- Decisions on a product's regulatory status stay with the competent authority of the member state where the manufacturer is registered, or with the Commission through implementing acts.
- The coordination mechanism should not act as a parallel post-certification review of CE-marked devices, and should be used for them only where substantiated evidence shows an unacceptable risk.
- Requirements for devices used in medicinal product trials, especially in vitro diagnostics, should be proportionate to their role, with guidance for cases where no suitable CE-marked device is available.
- Information for lay users may be accepted in other commonly understood Union languages, and where a device is for professional users only, information should be provided in English.
- The manufacturer decides whether a device is single-use or reprocessable, with justification in the technical documentation; devices not indicated as single-use may be reprocessed, and fully refurbished devices are treated as new.
- New definitions cover niche devices, breakthrough devices and orphan devices (affecting not more than 12,000 individuals in the Union per year), with prioritised assessment and expert panel advice.
- The removal of the equivalence contract requirement is reversed, so equivalence claims, especially for high-risk implants, need robust product-specific clinical evidence.
- Sponsors may submit a single application for combined studies, with coordinated assessment under Regulation (EU) No 536/2014 and no parallel application of the device regulations.
- Notified body designation and monitoring get fixed timelines, and full joint assessment team involvement is required every five years instead of every two, with more frequent involvement where justified.
- Member states may not require prior authorisation for device advertising but may act against non-compliant advertising after publication; importers may verify compliance through documentation and risk-based sampling.
Who is affected
- Manufacturers of medical devices and in vitro diagnostics: new rules on single-use designation, equivalence, quality audits and post-market reports.
- Notified bodies: fixed assessment timelines, risk-based surveillance and recognition of previous assessments.
- Health institutions and laboratories: in-house exemption conditions, including accreditation to EN ISO 15189.
- Importers and distributors: notification duties before relabelling or repackaging and risk-based verification of compliance.
- Patients and professional users: safeguards on clinical evidence, implant information and language of instructions.
Figures and deadlines
- Expert panel opinion on well-established technology within 30 days of a substantiated request.
- Expert panel opinion on regulatory status within 30 days of a complete request.
- Orphan devices: disease or condition affecting not more than 12,000 individuals in the Union per year.
- On-site assessment of a conformity assessment body within 90 days.
- Final assessment report to the MDCG within 15 days; draft designation decision within 15 days.
- Commission evaluation of a draft designation within 120 days of receipt of the referral.
- Annual assessment of a notified body by a joint assessment team at least every five years.
- National derogation authorising a device without conformity assessment for a period not exceeding 24 months.
Legal basis. Article 294(2) and Articles 168(4) and 114 of the Treaty on the Functioning of the European Union.
Text
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| Symbols for procedures |
| * Consultation procedure *** Consent procedure ***I Ordinary legislative procedure (first reading) ***II Ordinary legislative procedure (second reading) ***III Ordinary legislative procedure (third reading) (The type of procedure depends on the legal basis proposed by the draft act.) |
| Amendments to a draft act |
| Amendments by Parliament set out in two columns Deletions are indicated in bold italics in the left-hand column. Replacements are indicated in bold italics in both columns. New text is indicated in bold italics in the right-hand column. The first and second lines of the header of each amendment identify the relevant part of the draft act under consideration. If an amendment pertains to an existing act that the draft act is seeking to amend, the amendment heading includes a third line identifying the existing act and a fourth line identifying the provision in that act that Parliament wishes to amend. Amendments by Parliament in the form of a consolidated text New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced. By way of exception, purely technical changes made by the drafting departments in preparing the final text are not highlighted. |
Draft european parliament legislative resolution
on the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
–having regard to Article 294(2) and Articles 168(4) and 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C10-0360/2025),
2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) Any simplification of regulatory procedures should safeguard a high level of patient protection, maintain confidence in the safety and performance of medical devices, and ensure that streamlined processes do not weaken requirements for clinical evidence. |
It ensures that regulatory simplification does not compromise patient and product safety, reduce patient protection, or undermine confidence in the safety and performance of medical devices.
| Text proposed by the Commission | Amendment |
|---|---|
| (4b) Medical device software may require regular updates to improve functionality, usability, cybersecurity or interoperability. Updates that do not alter the intended purpose, clinical functionality or risk profile of the device should not automatically trigger a new full conformity assessment. Where software supports clinical decision-making, healthcare professionals should remain able to exercise their professional judgement, without prejudice to the manufacturer’s responsibility for the safety and performance of the device. |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) To ensure legal certainty and to safeguard the principle of free movement of goods, the coordination mechanism between national competent authorities for decisions on the regulatory status of a product and on the classification of a device, should be streamlined and, where appropriate, involve external expertise from an expert panel, supported by the European Medicines Agency (EMA). The decision on the regulatory status, however, should remain with the national authorities or, where appropriate, with the Commission acting through implementing acts. | (11) To ensure legal certainty and to safeguard the principle of free movement of goods, the coordination mechanism between national competent authorities for decisions on the regulatory status of a product and on the classification of a device, should be streamlined and, where appropriate, involve external expertise from an expert panel, supported by the European Medicines Agency (EMA). The decision on the regulatory status, however, should remain with the competent authority of the Member State in which the manufacturer has its registered place of business or, where appropriate, with the Commission acting through implementing acts. |
It clarifies that decisions on regulatory status are taken by the competent authority of the Member State where the manufacturer is registered, thereby ensuring legal certainty and reducing the risk of divergent assessments by different competent authorities.
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) For a device which has been subject to the conformity assessment procedure involving the participation of a notified body and which consequently bears the CE marking, the coordination mechanism should not beintended to operate as a parallel post-certification review in a manner that could affect legal certainty and the predictability of the certification process. Accordingly, that mechanism should be used in relation to such devices only where there is substantiated evidence that the device presents an unacceptable risk, due to its regulatory classification. |
It ensures that the functioning of the internal market and confidence in the CE marking system are not undermined by duplicative or unnecessary layers of regulatory oversight.
| Text proposed by the Commission | Amendment |
|---|---|
| (13a) For the conduct of clinical trials of medicinal products, including early-stage, exploratory and global trials, the requirements applicable to devices used in such trials, in particular in vitro diagnostic medical devices, should be proportionate to their role in the trial. Guidance should be developed on the circumstances in which adapted requirements may be warranted, in particular where no suitable CE-marked device is available, where a CE-marked device is used in relation to a different but closely related disease, condition, population or clinical context, or where the trial concerns a rare disease or condition. Such guidance should safeguard the safety, rights and well-being of trial subjects and ensure that the data generated are fit for purpose, while avoiding unnecessary duplication and delays in clinical research within the Union. |
It promotes a proportionate approach to the use of devices in medicinal product trials where suitable CE-marked devices may not be available, while ensuring patient safety and facilitating clinical research, including in early-stage, exploratory and rare disease settings.
| Text proposed by the Commission | Amendment |
|---|---|
| (15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory, Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations. | (15) While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the lay users within their territory, Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, in order to reduce costs for translations. Where a device is made available exclusively to professional users, information should be provided in English. |
It reflects that English is commonly used and understood in the medical field within the Union, in particular among professional users of medical devices.
| Text proposed by the Commission | Amendment |
|---|---|
| (21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing. | (21) The Commission Report14 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing. |
| 14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final). | 14 Report from the Commission to the European Parliament and the Council of 29 November 2024 on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and the Council on single-use devices and their reprocessing (COM(2024)560 final). |
It ensures that the classification of a device as single-use remains primarily based on patient safety considerations and the characteristics of the device.
| Text proposed by the Commission | Amendment |
|---|---|
| (31) To support innovation and the development and availability of breakthrough technology and of devices intended for small groups of patients, the conformity assessment procedures should be adapted to address the specific situation of those devices. For that purpose, criteria for breakthrough devices and orphan devices should be included in Regulations (EU) 2017/745 and (EU) 2017/746, based on guidance developed by the Medical Device Coordination Group. If the status as a breakthrough device or orphan device is confirmed by an expert panel, the review of the device by the notified body should be prioritised, if necessary with additional advice from the expert panels. | (31) To support innovation and the development and availability of breakthrough technology and of devices intended for small groups of patients, the conformity assessment procedures should be adapted to address the specific situation of those devices. For that purpose, criteria for breakthrough devices and orphan devices should be included in Regulations (EU) 2017/745 and (EU) 2017/746, based on guidance developed by the Medical Device Coordination Group. Where feasible, the criteria and data requirements under those schemes should reflect applicable Union and international approaches. If the status as a breakthrough device or orphan device is confirmed by an expert panel, the review of the device by the notified body should be prioritised, if necessary with additional advice from the expert panels. Only expert panels and notified bodies with the necessary clinical, scientific, technical and regulatory expertise and capabilities should be involved in the assessment of breakthrough or orphan devices. |
It ensures a proportionate and expertise-based framework for breakthrough and orphan devices, facilitating innovation and timely access for small patient populations while maintaining appropriate scientific and regulatory scrutiny.
| Text proposed by the Commission | Amendment |
|---|---|
| (39) Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted. | deleted |
It ensures that equivalence claims, particularly for high-risk implantable devices, remain subject to robust and product-specific clinical evidence, thereby safeguarding patient safety and maintaining incentives for manufacturers to generate their own clinical data.
| Text proposed by the Commission | Amendment |
|---|---|
| (43) There is a growing number of clinical studies involving, simultaneously, a clinical trial of a medicinal product subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council20 , a performance study of an in vitro diagnostic medical device subject to Regulation (EU) 2017/746 or a clinical investigation of a medical device subject to Regulation (EU) 2017/745 (‘combined studies’). To address concerns raised regarding the complexity of applying multiple Regulations to those combined studies, sponsors should be enabled to submit a single application for a combined study leading to its coordinated assessment under Regulation (EU) No 536/2014. Regulations (EU) 2017/746 and Regulation (EU) 2017/745 should not be applicable where a single application has been submitted. | (43) There is a growing number of clinical studies involving, simultaneously, a clinical trial of a medicinal product subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council20 , a performance study of an in vitro diagnostic medical device subject to Regulation (EU) 2017/746 or a clinical investigation of a medical device subject to Regulation (EU) 2017/745 (‘combined studies’). To address concerns raised regarding the complexity of applying multiple Regulations to those combined studies, sponsors should be enabled to submit a single application for a combined study leading to its coordinated assessment under Regulation (EU) No 536/2014. Regulations (EU) 2017/746 and Regulation (EU) 2017/745 should not be applicable where a single application has been submitted. The use of a single application for combined studies should facilitate the conduct of clinical trials falling under Regulation (EU) 2017/536 and Regulation (EU) 2017/746 by reducing procedural complexity for studies involving diagnostic tests. To ensure its effective application, overlaps with the EUDAMED system for submissions relating to clinical investigations and performance studies should be avoided. Experience gained from the COMBINE programme should be taken into account in the implementation of this Regulation. |
| 20 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.1, ELI; http://data.europa.eu/eli/reg/2014/536/oj). | 20 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.1, ELI; http://data.europa.eu/eli/reg/2014/536/oj). |
It ensures a flexible implementation of the mechanism that can be refined in light of experience gained from the COMBINE pilot project on coordinated assessment of combined studies.
| Present text | Amendment |
|---|---|
| (1a) Article 1(9) is replaced by the following: | |
| Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product. | "9. Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product. |
| However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned. | However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, only the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned." |
(This amendment seeks to amend a provision within the existing act – Article 1(9) – that was not referred to in the Commission proposal.)
It avoids duplicative MDR obligations where the product is already assessed under the pharmaceutical legislation and improves legal certainty.
| Text proposed by the Commission | Amendment |
|---|---|
| (48) ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from any of the following: | (48) ‘clinical data’ means information concerning safety or performance that is generated from the clinical or investigational use of a device and is sourced from any of the following: |
This clarifies that clinical data is information generated from clinical and/or investigational use of a device, reflecting internationally recognised terminology.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it has not been associated with safety issues in the past; | (b) it has a well-known safety history and has not been associated with safety issues in the past; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) The following points are added: | |
| ‘(77): 'niche devices' means a device intended for a specific clinical use, procedure or patient subgroup, which is made available on the Union market only in limited volumes due to the specific nature of its intended purpose, and for which no suitable alternative is available or the absence of the device would adversely affect patient care. | |
| Additionally, A device shall also be considered a niche device if an expert panel referred to in Article 106 provides an opinion as to whether the criteria are fulfilled; | |
| (78) 'breakthrough device' means a novel medical device or in vitro diagnostic medical device expected to provide a significant clinical benefit through a substantial advancement over existing alternatives or by addressing an unmet medical need; | |
| (79): 'orphan devices' means a medical device or in vitro diagnostic medical device intended for a disease or condition affecting not more than 12,000 individuals in the Union per year and which fulfils an unmet medical need by providing a diagnosis, prevention, monitoring or treatment for which no satisfactory alternative exists.’; |
It ensure legal certainty for products that are essential for patient care but are not explicitly covered by the orphan or breakthrough device pathways. Such devices may serve very small clinical uses or patient subgroups and risk disappearing from the market due to disproportionate regulatory burdens.
| Present text | Amendment |
|---|---|
| (2a) Article 2, point (44), is replaced by the following: | |
| (44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer; | "(44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data, or non-clinical data where Article 61(10) applies, pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;" |
(This amendment seeks to amend a provision within the existing act – Article 2, point (44) – that was not referred to in the Commission proposal.)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion within 30 days as to whether a specific device or a generic device group is a well-established technology. The opinion shall be taken into account by the competent authority and the notified body in the appropriate conformity assessment procedure. | |
| The opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category, or group of products, falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. | 1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category, or group of products, that has been placed on the market falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. |
It clarifies that the procedure applies only once products have been placed on the market. It avoids uncertainty for products that are still under development.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, considers that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question. | 3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, has substantiated evidence that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question. The consulting competent authority shall inform the concerned manufacturer and concerned notified body that has issued the certificate. |
It requires substantiated evidence before re-opening the regulatory status of a CE-marked product. It ensures early information of the manufacturer and Notified Body in order to strengthen legal certainty.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The results of the coordination activities of the competent authorities in accordance with this Article and the opinions of the expert panel delivered in accordance with paragraph 4 of this Article and Article 4a(2) shall be made publicly available, without disclosing any confidential information as referred to in Article 109. | 5. The results of the coordination activities of the competent authorities in accordance with this Article and the opinions of the expert panel delivered in accordance with paragraph 4 of this Article shall be made publicly available, without disclosing any confidential information as referred to in Article 109. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Where necessary, to ensure the uniform application of this Regulation, and taking into account the opinion of the expert panel referred to in paragraph 4, the Commission may, by means of implementing acts, determine whether a product, CE-marked in accordance with Article 20, falls within the scope of this Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Commission may, by means of implementing acts, lay down the procedure, including timelines, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).; | 6. The Commission shall, by means of implementing acts, lay down the procedure, including timelines and involvement of concerned stakeholders, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII. | 1. A competent authority, may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII. |
It limits the expert panel procedure to substantiated requests by competent authorities concerning specific products. It prevents the procedure from being used for broad or strategic reassessments and preserves legal certainty for products already covered by Article 4.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The expert panel shall provide its opinion without undue delay. The requester shall give utmost consideration to the opinion of the expert panel. | 2. The expert panel shall provide its opinion within 30 days from receipt of a complete request. The requester shall give utmost consideration to the opinion of the expert panel when determining the regulatory status of the product. |
| Any opinion of an expert panel in relation to the determination of the regulatory status, shall be made publicly available, without disclosing any confidential information as referred to in Article 109. |
| Text proposed by the Commission | Amendment |
|---|---|
| Having regard to the expert panel opinion referred to in paragraph 2 or in Article 4(4), a Member State may submit a substantiated request to the Commission to determine whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall decide on the substantiated request of the Member State or on its own initiative, by means of implementing acts, which shall be adopted in accordance with the examination procedure referred to in Article 114(3). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may ask the expert panel for clarifications or refer the opinion back to the expert panel for further consideration, including in cases where a Member State’s substantiated request raises new questions of a scientific or technical nature. | deleted |
| Present text | Amendment |
|---|---|
| (5a) Article 5(5) is replaced by the following: | |
| 5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: | "5. With the exception of the relevant general safety and performance requirements set out in Annex I, applied in a proportionate manner, having regard to the non-commercial nature and intended use of the device, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:" |
(This amendment seeks to amend a provision within the existing act – Article 5(5) – that was not referred to in the Commission proposal.)
| Present text | Amendment |
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| (6a) in Article 5(5), point (e) is deleted; | |
| (e) the health institution draws up a declaration which it shall make publicly available, including: | "" |
| (i) the name and address of the manufacturing health institution; | |
| (ii) the details necessary to identify the devices; |
(This amendment seeks to amend a provision within the existing act – Article 5(5) – that was not referred to in the Commission proposal.)
It removes a disproportionate publication requirement for non-commercial in-house devices, reducing administrative burden for health institutions while preserving the purpose of the in-house exemption.
| Text proposed by the Commission | Amendment |
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| Manufacturers may rely on relevant results from audits or certifications carried out under internationally recognised quality management schemes, including ISO 13485 and the Medical Device Single Audit Program (MDSAP), where such results are suitable to demonstrate compliance with the quality management system requirements of this Regulation. |
It allows relevant results from internationally recognised quality management audits to be taken into account for MDR compliance, helping to avoid duplicative assessments, reducing unnecessary administrative burden and enabling notified bodies to focus resources on risk-relevant aspects.
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| (c) paragraph 10 is deleted; | deleted |
| Text proposed by the Commission | Amendment |
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| When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).; | When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s). Where a device is intended exclusively for professional use, the information referred to in Section 23 of Annex I may be provided only in English. |
| Text proposed by the Commission | Amendment |
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| (e) paragraph 13 is deleted; | deleted |
| Text proposed by the Commission | Amendment |
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| (f) paragraph 14 is amended as follows: | deleted |
| (i) the third subparagraph is deleted; | |
| (ii) the fourth subparagraph is deleted; |
| Text proposed by the Commission | Amendment |
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| (h) paragraph 16 is deleted; | deleted |
| Text proposed by the Commission | Amendment |
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| (ha) the following paragraph 16a is added: | |
| 16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Economic operators liable under Article 8 of Directive (EU) 2024/2853 shall ensure that they have appropriate financial coverage, including insurance or equivalent arrangements, for their potential liability before placing a device on the market, putting it into service or making it available.The level of coverage shall be proportionate to the risk class, intended purpose and potential harm associated with the device, without prejudice to stricter protective measures under national law. |
It strengthens patient and user protection by requiring economic operators liable for defective devices to maintain appropriate financial coverage for potential compensation claims.
| Text proposed by the Commission | Amendment |
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| (11) in Article 11, paragraphs 4 and 5 are deleted; | deleted |
The original text maintains existing liability rules for authorised representatives. Where defective devices are placed on the Union market by manufacturers established outside the Union, patients and users must retain an effective route to compensation and accountability within the Union.
| Text proposed by the Commission | Amendment |
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| (b) paragraph 4 is deleted; | (b) paragraph 4 is replaced by the following: |
| ‘4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer of their intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.’ |
It preserves manufacturer oversight where devices are relabeled or repackaged by importers or distributors ensuring traceability and effective vigilance and post-market surveillance as well as corrective actions where necessary.
| Text proposed by the Commission | Amendment |
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| 1. A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II. | 1. It shall be the responsibility of the manufacturer to indicate whether a device is intended for single-use or whether it may be reprocessed. This indication shall be based on the design, construction, materials and chemical, physical and biological properties of the device and shall be included in the technical documentation referred to in Annex II. |
| Where a device intended exclusively for professional use in health institutions is designated as single-use, the manufacturer shall include a reasoned justification in the technical documentation explaining why safe reprocessing cannot be ensured. |
It ensure that a single-use decision remains with the manufacturer, who has the technical knowledge of the device and is responsible for its safety and performance. At the same time, it requires additional justification for devices used only in hospitals, to avoid unnecessary single-use designation where safe reprocessing may be possible.
| Text proposed by the Commission | Amendment |
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| 2. If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n). | 2. If the device is not intended for single-use, 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). For any reprocessed device, the label shall indicate that it has been reprocessed and shall include the name and address of the reprocessor to ensure traceability. |
| Text proposed by the Commission | Amendment |
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| 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 are no longer suitable for further reprocessing, 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. |
| Text proposed by the Commission | Amendment |
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| 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 the general and harmonised requirements for the reprocessing or fully refurbishing of devices. |
| Text proposed by the Commission | Amendment |
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| (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;’ |
Patients continue to receive essential information on implanted devices, even where the implant is considered well-established technology.
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| (19a) Article 27(1), point (a)(i), is replaced by 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;" |
| Text proposed by the Commission | Amendment |
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| 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative, the importer and the person referred to in Article 22(1). The details regarding the information to be provided to that electronic system by the economic operators are laid down in Part A, Section 1, of Annex VI.; | 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative, the importer and the person referred to in Article 22(1). The details regarding the information to be provided to that electronic system by the economic operators are laid down in Part A, Section 1, of Annex VI. In addition to the information referred to in Part A of Annex VI, manufacturers and authorized representatives shall provide the information required to determine the size in accordance with 2003/361/EC. |
Allows the SME status of manufacturers to be recorded directly in Eudamed. This creates a reliable basis for SME-related measures, such as fee reductions, and reduces the need for separate reporting.
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| 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 applicable, to the patient, and shall be made available to the public via Eudamed. |
| Text proposed by the Commission | Amendment |
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| (b) in paragraph 2, point (h) is replaced by the following: | deleted |
| ‘(h) information on any residual risks or undesirable effects, and any warnings and precautions.;’ |
| Text proposed by the Commission | Amendment |
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| Unless the application is rejected, the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, that is to be involved in the conformity assessment process. | Unless the application is rejected, the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, that is to be involved in the conformity assessment process within 90 days. |
It improves the predictability and efficiency of the designation procedure by introducing a clear timeframe for the conduct of on-site assessments.
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| The joint assessment team shall submit its final assessment report to the MCDG without undue delay. | The joint assessment team shall submit its final assessment report to the MCDG within 15 days. |
It improves the predictability and efficiency of the designation procedure by introducing a clear timeframe for the conduct joint assessments.
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| Based on the findings of the final assessment report, the authority responsible for notified bodies shall submit to the MDCG a draft decision on the designation of the notified body or reject the application. | Based on the findings of the final assessment report, the authority responsible for notified bodies shall submit to the MDCG a draft decision on the designation of the notified body or reject the application within 15 days. |
It improves the predictability and efficiency of the designation procedure by introducing a clear timeframe for the conduct of assessments reports.
| Text proposed by the Commission | Amendment |
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| 13. Where the authority responsible for notified bodies does not agree with the recommendation of the MDCG, it shall submit to the MDCG a duly justified request to reconsider its recommendation. Within 30 days of receipt of that request, the MDCG shall either confirm its recommendation or issue a new recommendation. | 13. Where the authority responsible for notified bodies does not agree with the recommendation of the MDCG, it shall submit to the MDCG a duly justified request to reconsider its recommendation within this period. Within 30 days of receipt of that request, the MDCG shall either confirm its recommendation or issue a new recommendation. |
It improves the predictability and efficiency of the designation procedure by introducing a clear timeframe for the conduct of on-site assessments.
| Text proposed by the Commission | Amendment |
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| Within 180 days of receipt of the referral, the Commission shall, after consulting the MDCG, the authority responsible for notified bodies and, where necessary, the applicant conformity assessment body concerned, evaluate the draft decision on the designation and decide, by means of implementing act, whether or not the draft designation is justified. | Within 120 days of receipt of the referral, the Commission shall, after consulting the MDCG, the authority responsible for notified bodies and, where necessary, the applicant conformity assessment body concerned, evaluate the draft decision on the designation and decide, by means of implementing act, whether or not the draft designation is justified. |
| Text proposed by the Commission | Amendment |
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| At least every two years, the annual assessment of a notified body shall be carried out by a joint assessment team including the authority responsible for notified bodies and two experts from the list referred to in Article 40(2) appointed by the Commission in consultation with the MDCG. At least one of those experts shall be an expert representing the Commission. In light of the specific circumstances of the monitoring, the Commission may appoint a different number of experts. The joint assessment team shall be coordinated by the expert representing the Commission. | At least every five years, the annual assessment of a notified body shall be carried out by a joint assessment team including the authority responsible for notified bodies and two experts from the list referred to in Article 40(2) appointed by the Commission in consultation with the MDCG. At least one of those experts shall be an expert representing the Commission. In light of the specific circumstances of the monitoring, the Commission may appoint a different number of experts. The joint assessment team shall be coordinated by the expert representing the Commission. In duly justified cases and where necessary, the joint assessment team may be involved more frequently. |
It reduces unnecessary administrative burden by requiring full Joint Assessment Team involvement every five years instead of every two years. More frequent involvement remains possible where there are specific concerns, so effective oversight is preserved.
| Text proposed by the Commission | Amendment |
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| If, at any stage of the process, consensus cannot be reached within the joint assessment team on any issue, any member of the joint assessment team may refer the issue to the MDCG, which shall provide its views without undue delay and at the latest within 60 days from the referral. | Where consensus cannot be reached within the Joint Assessment Team, any member may refer the matter to the MDCG, which shall provide its views without undue delay and no later than 60 days from referral. |
| Text proposed by the Commission | Amendment |
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| At the end of any assessment carried out pursuant to paragraph 4 or 4a, the authority responsible for notified bodies or the joint assessment team, as applicable, shall inform the notified body about any non-compliances resulting from the assessment and summarise their assessment. | At the end of any assessment carried out pursuant to paragraph 4 or 4a, the authority responsible for notified bodies or the joint assessment team, as applicable, shall inform the notified body about any non-compliances resulting from the assessment and summarise their assessment within 20 days. |
| Text proposed by the Commission | Amendment |
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| The authority responsible for notified bodies or the joint assessment team, as applicable, shall assess whether the non-compliances identified during the assessment have been appropriately addressed in the plan referred to in the second subparagraph and, where necessary, provide any comments on the plan to the notified body, including requests for further clarification and modifications. The notified body and the authority or the joint assessment team, as applicable, shall endeavour to agree on a final corrective and preventive action plan in due course. | The authority responsible for notified bodies or the joint assessment team, as applicable, shall assess whether the non-compliances identified during the assessment have been appropriately addressed in the plan referred to in the second subparagraph and, where necessary, provide any comments on the plan to the notified body, including requests for further clarification and modifications within 30 days. The notified body and the authority or the joint assessment team, as applicable, shall endeavour to agree on a final corrective and preventive action plan in due course. |
| Text proposed by the Commission | Amendment |
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| After receipt of the final corrective and preventive action plan, or where the authority responsible for notified bodies or the joint assessment team, as applicable, have not identified non-compliances or conclude that no agreement on a final plan has been reached, the authority or the joint assessment team, as applicable, shall draw up their final monitoring report which shall include the result of the assessment and, where applicable, conclusions regarding the corrective and preventive action plan and, where applicable, any recommendations regarding the notified body’s designation. | After receipt of the final corrective and preventive action plan, or where the authority responsible for notified bodies or the joint assessment team, as applicable, have not identified non-compliances or conclude that no agreement on a final plan has been reached, the authority or the joint assessment team, as applicable, shall draw up their final monitoring report within 30 days which shall include the result of the assessment and, where applicable, conclusions regarding the corrective and preventive action plan and, where applicable, any recommendations regarding the notified body’s designation. |
| Text proposed by the Commission | Amendment |
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| The authority responsible for notified bodies or the joint assessment team, as applicable, shall submit their final monitoring report to the MDCG without undue delay. | The authority responsible for notified bodies or the joint assessment team, as applicable, shall submit their final monitoring report to the MDCG within 10 days. |
| Text proposed by the Commission | Amendment |
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| 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. Notified bodies shall implement the outcome of the coordination in their practical work without undue delay. 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. |
| Present text | Amendment |
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| (41a) In Article 51(3), introductory part is replaced by the following: | |
| 3. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: | "3. A requester as referred in Article 51b(1), may submit a substantiated request to the Commission, to decide, after consulting an expert panel, referred to in Article 106, by means of implementing acts, on the following:" |
(This amendment seeks to amend a provision within the existing act – Article 51(3) – that was not referred to in the Commission proposal.)
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| (41b) Article 51(4) is replaced by the following: | |
| 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. | "4. The Commission may also, on its own initiative and after consulting an expert panel, referred to in Article 106, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3." |
(This amendment seeks to amend a provision within the existing act – Article 51(4) – that was not referred to in the Commission proposal.)
| Text proposed by the Commission | Amendment |
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| 2. Within 30 days of receipt of the referral referred to in paragraph 1, the competent authority shall consult the other Member States regarding its draft classification decision. | 2. Within 30 days of receipt of the referral, referred to in paragraph 1, the competent authority shall consult an expert panel, referred to in Article 106, regarding its draft classification decision. |
| Text proposed by the Commission | Amendment |
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| 3. Where, within 30 days of receipt of the consultation referred to in the paragraph 2, no substantiated disagreement has been 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. The expert panel, referred to in Article 106, shall consult the notified body and the manufacturer concerned before issuing its opinion. |
| Text proposed by the Commission | Amendment |
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| 4. Where, within 30 days of receipt of the consultation referred to in paragraph 2, a substantiated disagreement has been raised by a Member State regarding the draft classification decision, the matter shall be referred to an expert panel as referred to in Article 106. That expert panel shall deliver an opinion on the classification of the device within 30 days. The competent authority may ask the expert panel for clarifications on its opinion. | 4. The expert panel, referred to in Article 106, shall deliver an opinion on the classification of the device within 30 days. The competent authority may ask the expert panel for clarifications on its opinion. |
| Text proposed by the Commission | Amendment |
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| 5. Within 30 days of receipt of the expert panel opinion, or any requested clarification, referred to in paragraph 4, the competent authority shall adopt its decision, giving utmost consideration to the expert panel opinion. It shall notify the other Member States and the Commission of its decision without undue delay. | 5. Within 30 days of receipt of the expert panel opinion, or any requested clarification, the competent authority shall adopt its decision. The competent authority shall follow the expert panel opinion, unless it provides duly justified reasons for departing from it. It shall notify the other Member States and the Commission of its decision without undue delay. |
| Text proposed by the Commission | Amendment |
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| 5a. Any opinion of an expert panel in relation to classification, shall be made publicly available, without disclosing any confidential information as referred to in Article 109. |
| Text proposed by the Commission | Amendment |
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| 5b. On the basis of an expert panel opinion issued under this Article, the Commission may, on its own initiative or following a substantiated request, adopt an implementing act to clarify the classification of a specific product under Annex VIII. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 114(3). |
| Text proposed by the Commission | Amendment |
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| 4a. Expert panel opinions issued under this Article shall be made publicly available, without disclosing confidential information as referred to in Article 109. |
This Article strengthens the role of expert panels in complex classification questions by allowing substantiated requests for scientific and technical opinions. It improves consistency and legal certainty while ensuring that final classification decisions remain within the established regulatory framework.
| Text proposed by the Commission | Amendment |
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| Challenges to the classification of CE marked devices | Challenges to the classification |
| Text proposed by the Commission | Amendment |
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| 1. Where a competent authority, after having performed an evaluation in accordance with Article 94, considers that a device that is CE marked in accordance with Article 20, is not classified in accordance with Annex VIII, it shall consult the other Member States regarding its envisaged measure on the classification of the device. | 1. In cases of uncertainty concerning the classification of a specific product under Annex VIII, a competent authority, notified body, manufacturer, product developer or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106. |
| Text proposed by the Commission | Amendment |
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| 2. Where, within 30 days of receipt of the consultation referred to in paragraph 1, no substantiated disagreement is raised by a Member State, the competent authority may adopt the measure on the classification of the device in question and shall notify the other Member States and the Commission of its decision giving the reasons for the decision. | 2. Where the request concerns a device that is CE marked in accordance with Article 20, the expert panel shall, before issuing its opinion, consult the competent authority of the Member State in which the manufacturer has its registered place of business, the manufacturer and, where applicable, the notified body concerned. |
| Text proposed by the Commission | Amendment |
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| 3. Where, within 30 days of receipt of the consultation referred to in paragraph 1, a substantiated disagreement is raised by a Member State regarding the envisaged measure on the classification, the matter shall be referred to an expert panel referred to in Article 106, which shall deliver an opinion on the classification of the device within 30 days. The competent authority may ask the expert panel for clarifications on its opinion. | 3. The expert panel shall provide its opinion within 90 days from receipt of a complete request. The opinion shall include the reasons for the proposed classification. |
| Text proposed by the Commission | Amendment |
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| 4. The competent authority shall give utmost consideration to the expert panel opinion. Where the competent authority adopts a measure on the classification, it shall notify the other Member States and the Commission of its measure without undue delay.; | 4. The requester and the competent authority concerned shall duly take the expert panel opinion into account in any subsequent classification decision or measure. |
| Text proposed by the Commission | Amendment |
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| (ea) In Article 52(7), the following subparagraph 2 is added: | |
| In implementing this Article, Member States shall not require prior approval or notification of advertising for devices. Member States may take appropriate ex-post measures, including prohibiting or sanctioning advertising that does not comply with this Article, in accordance with Union and national law. |
It prevents divergent national prior authorisation for advertising of medical devices, which could create barriers in the internal market but preserves the ability of Member States to act against misleading or non-compliant advertising after publication.
| Text proposed by the Commission | Amendment |
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| (b) the modalities of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device, | (b) the modalities of surveillance audits in accordance with Section 3.3 of Annex IX, and of unannounced on-site audits and sample tests in accordance with Section 3.4 of Annex IX, taking into account the manufacturer’s compliance history, the risk class and the type of device; |
Ensures that surveillance audits, unannounced audits and sample tests are organised in a risk-based and proportionate way. Taking account of the manufacturer’s compliance history allows notified bodies to reduce burden where performance is stable while maintaining stronger oversight where specific risks or past compliance issues exist.
| Text proposed by the Commission | Amendment |
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| 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 niche 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. |
| Text proposed by the Commission | Amendment |
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| (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 as referred to in Article 83(1) of the Directive 2001/83/EC. |
| Text proposed by the Commission | Amendment |
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| 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, orphan device or niche device, and the sponsor of the relevant clinical trials, 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. |
| Text proposed by the Commission | Amendment |
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| 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, orphan device or niche 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, including relevant subsequent changes, and apply, where appropriate, a rolling review with a view to reducing assessment timelines. |
| Text proposed by the Commission | Amendment |
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| 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. |
| Text proposed by the Commission | Amendment |
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| 6a. For companion diagnostics and drug-device products linked to a medicinal product subject to an accelerated assessment or other expedited regulatory pathway, the notified body shall, where appropriate, prioritise the conformity assessment and apply a rolling review with a view to aligning the assessment timeline with that of the corresponding medicinal product. |
| Text proposed by the Commission | Amendment |
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| 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 are fulfilled: |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 validity of the initial certificate shall be limited to a maximum of five years. The notified body shall specify any conditions for the certificate’s validity in accordance with Article 56, including, where necessary, specific post-market clinical follow-up activities within a defined timeframe. The certificate may be renewed where the manufacturer has demonstrated compliance with the applicable post-market clinical follow-up requirements. |
It ensures that earlier market access based on limited clinical data is balanced by clear safeguards. A time-limited initial certificate and binding post-market clinical follow-up requirements ensure that additional evidence is generated after market entry.
| Text proposed by the Commission | Amendment |
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| Only expert panels and notified bodies with appropriate clinical, scientific, technical and regulatory expertise shall be involved in the evaluation of breakthrough devices, orphan devices or niche devices. |
| Text proposed by the Commission | Amendment |
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| 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 niche devices set out in this Article, including mechanisms for prioritisation and rolling review by notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| 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, and of class IIb and III breakthrough devices and orphan devices and niche devices as referred to in Article 52a of this Regulation. |
It ensures that devices with higher risk profiles remain subject to independent expert scrutiny of their clinical evidence, particularly where market access may be based on limited clinical data.
| Text proposed by the Commission | Amendment |
|---|---|
| 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 in accordance with the applicable Annex for the conformity assessment procedure under which the certificate was issued. Such surveillance activities shall be proportionate to the risk class of the device and shall not amount to a full reassessment equivalent in scope to the conformity assessment performed for the issuance of the certificate. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 period not exceeding 24 months 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.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. 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 that the provision of that service is in the interest of public health, patient safety or patient health.; | 1a. By way of derogation from Article 6(2) and on a duly justified request, any competent authority may authorise for a period not exceeding 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 for which the applicable conformity assessment procedures set out in this Regulation have not been carried out, provided that the provision of that service is in the interest of public health, patient safety or patient health.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 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, may, by means of implementing acts, extend for a period not exceeding 24 months 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).; |
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. Participation in a regulatory sandbox shall not mean that the requirements regarding conformity assessment under this Regulation are deemed to have been fulfilled. |
| Text proposed by the Commission | Amendment |
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| 5a. Participation in a regulatory sandbox shall not mean that the requirements regarding conformity assessment under this Regulation are deemed to have been fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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, different from a class III implantable, 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, including clinical data from a clinical investigation of the equivalent device, has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body. |
Introduces a risk-based approach to the use of equivalence. Ensures that reliance on equivalence is only possible where the equivalent device is supported by clinical data generated in accordance with MDR requirements. This prevents outdated or insufficiently evidenced devices from being used as benchmarks for new products.
| Text proposed by the Commission | Amendment |
|---|---|
| 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 are relevant for the confirmation of safety and performance of the device or demonstrate a significant change in the benefit-risk determination. |
| Present text | Amendment |
|---|---|
| (ca) paragraph 14 is replaced by the following: | |
| 14. The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it. After 27 May 2027, all Member States shall be required to apply that procedure. | "14. The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it. All Member States shall be required to apply the procedure set out in this Article from the date corresponding to 2 years from the date of publication of the notice referred to in Article 34(3), informing that the electronic system referred to in Article 33(2), point (e), is functional and meets the functional specifications drawn up pursuant to Article 34(1)." |
(This amendment seeks to amend a provision within the existing act – Article 78(14) – that was not referred to in the Commission proposal.)
The reduction of the time period and removal of the application phase will reduce administrative burden and improve regulatory certainty.
| Text proposed by the Commission | Amendment |
|---|---|
| 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 devices and class III devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter, and whenever 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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 and non-implantable class IIb devices shall update the PSUR at least once in the first two years after the certificate is issued and when necessary. The PSUR shall be part of the technical documentation specified in Annex III. |
| Text proposed by the Commission | Amendment |
|---|---|
| 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, including experts from notified bodies, in the field of medical devices or in vitro diagnostic medical devices reflecting the diversity of scientific and clinical approaches in the Union. |
It strengthens early coordination between expert panels and notified bodies, thereby improving regulatory predictability and reducing the risk of delays in the development of medical devices and in vitro diagnostic medical devices.
| Text proposed by the Commission | Amendment |
|---|---|
| 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' organisations, healthcare professionals’ associations and industry associations. |
It ensures that expert panels have access to all relevant stakeholder input in order to support comprehensive and well-informed assessments.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from Article 5 and from paragraphs 3 to 3e of this Article, a device as referred to in paragraph 3a or 3b of this Article that meets the criteria for an orphan device as referred to in Article 52a(3) may be placed on the market or put into service after the dates referred to in paragraphs 3a and 3b of this Article if the following conditions are met: | By way of derogation from Article 5 and from paragraphs 3 to 3e of this Article, a device as referred to in paragraph 3a or 3b of this Article that meets the criteria for an orphan device or niche device as referred to in Article 52a(3) or a niche device may be placed on the market or put into service after the dates referred to in paragraphs 3a and 3b of this Article if the following conditions are met: |
It ensures that the derogation also covers niche devices, thereby safeguarding the continued availability of specialised medical devices for limited patient populations.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the laboratory of the health institution is compliant with standard EN ISO 15189 or, where applicable, national provisions for quality and competence in medical laboratories, including national provisions regarding accreditation;; | (c) the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation or an equivalent internationally recognised standard. Laboratories established outside the Union shall be accredited to EN ISO 15189 or an equivalent internationally recognised standard by a recognised national accreditation body or equivalent authority. |
It ensures an equivalent level of quality and competence for laboratories, including those located outside the Union, by recognising internationally accepted accreditation standards and maintaining consistent safety and performance requirements.
| Text proposed by the Commission | Amendment |
|---|---|
| This paragraph shall also apply to devices manufactured and used within a laboratory that is established in the Union and provides consistent, state of the art testing services for clinical research, provided those devices are intended exclusively for use in the framework of a clinical trial subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council*. Where, in this paragraph, reference is made to a health institution, such reference shall also be understood as reference to a laboratory referred to in the first sentence of this subparagraph. | This paragraph shall also apply to devices manufactured and used within a laboratory that provides consistent, state of the art testing services for clinical research, provided those devices are intended exclusively for use in the framework of a clinical trial subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council*. Where, in this paragraph, reference is made to a health institution, such reference shall also be understood as reference to a laboratory referred to in the first sentence of this subparagraph. |
It ensures consistent application of the provision to laboratories performing testing services for clinical research within the framework of clinical trials under Regulation (EU) No 536/2014.
| Present text | Amendment |
|---|---|
| (aa) in paragraph 5, the introductory part is replaced by the following: | |
| 5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: | "5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union or located outside of the Union that are accredited by a recognised national accreditation body or equivalent authority, provided that all of the following conditions are met:" |
It ensures that the exemption from regulatory requirements also applies to equivalent health institutions outside the Union, provided that they are subject to recognised accreditation standards ensuring an equivalent level of quality, safety and competence.
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) In Article 7, the following subparagraph 3 is added: | |
| 'Member States shall not introduce or maintain prior authorisation or similar ex-ante administrative requirements for the advertising of devices. Member States may ensure enforcement of this Article through ex-post measures, including the prohibition or sanctioning of advertising practices that do not comply with this Regulation, in accordance with Union and national law.' |
It maintains harmonised Union rules for the advertising of medical devices by preventing national prior authorisation or notification schemes, thereby safeguarding the free movement of goods and legal certainty, while preserving Member States’ ability to address non-compliant advertising through market surveillance.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) paragraph 8 is amended as follows: | (b) deleted |
It preserves a clear and standardised reference framework for all components, thereby ensuring consistency across manufacturers.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) paragraph 9 is deleted; | (c) paragraph (9) is replaced by the following: |
| 'Manufacturers may use audit results conducted under internationally recognised quality management schemes, including ISO 13485 certification and the Medical Device Single Audit Program (MDSAP), to demonstrate compliance with the quality management system requirements of this Regulation.'; |
It enables manufacturers to rely on audits and certifications from internationally recognised programmes for demonstrating compliance with quality management system requirements, thereby reducing duplication and administrative burden.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) paragraph 4 is deleted; | (b) At least 28 days prior to making a relabelled or repackaged device available on the market, distributors or importers carrying out the activities referred to in points (a) and (b) of paragraph 2 shall notify the manufacturer of their intention to place the relabelled or repackaged device on the market and shall, upon request, provide a sample or mock-up of the relabelled or repackaged device, including translated labelling and instructions for use. |
It ensures timely and accurate information on relabelling and repackaging activities, thereby safeguarding supply chain integrity and enabling effective product oversight throughout the lifecycle.
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. Participation in a regulatory sandbox shall not be considered as fulfilling the conformity assessment requirements under this Regulation. |
It clarifies that participation in a regulatory sandbox does not affect the applicable conformity assessment requirements and that all devices remain subject to the same regulatory scrutiny.
| Text proposed by the Commission | Amendment |
|---|---|
| (51a) in Article 78, the following paragraph 5 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. ’; |
This article clarifies that post-market surveillance activities are carried out under the safeguards of the GDPR for scientific research purposes, therefore enabling proportionate data use for product safety and innovation while ensuring an appropriate level of data protection.
| Present text | Amendment |
|---|---|
| 1a. Article 13(2) is replaced by the following: | |
| 2. In order to place a device on the market, importers shall verify that: | "'2. In order to place a device on the market, importers shall have the evidence that: |
| (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; | (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; |
| (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer; | (b) a manufacturer and an authorized representative, if applicable, are identified; |
| (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; | (c) the device is accomplished by physical or digital label in accordance with this Regulation and accompanied by the required instructions for use; |
| (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24. | (d) where applicable, a UDI has been assigned by the manufacturer. |
| Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established. | To verify compliance with points (a) to (d) of the first subparagraph, importers may rely on the documentation supplied with the device or apply risk-based sampling methods taking into account the risk class of the devices they import. Where an importer has reason to believe that a device is not in conformity with this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative. Where the importer has reason to believe that the device presents a serious risk or is falsified, it shall also inform the competent authority of the Member State in which it is established.'" |
(This amendment seeks to amend a provision within the existing act – Article 13(2) – that was not referred to in the Commission proposal.)
It introduces a more risk-based and proportionate approach to importer obligations, allowing compliance to be verified through appropriate documentation and risk-based sampling rather than full re-assessment of each product, hence reducing duplication and administrative burden while maintaining a high level of safety and market surveillance.
| Text proposed by the Commission | Amendment |
|---|---|
| in point (f), the reference to ‘Regulation (EU) No 207/2012’ is replaced by the reference to ‘Commission Implementing Regulation (EU) 2021/2226** | Instructions for use may be provided to the user in non-paper format such as electronic format. Users shall have the possibility to obtain instructions for use in paper format upon request. |
It facilitates the use of electronic instructions for use, while ensuring that users retain the right to request and receive instructions in paper format to guarantee accessibility for all user groups.
| Present text | Amendment |
|---|---|
| (1a) Section 12.2 is replaced by the following: | |
| Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation. | "Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall be assessed for aspects relating to the absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation and taking into account the state of the art and the characteristics of the substances." |
(This amendment seeks to amend a provision within the existing act – Section 12.2 of Annex I – that was not referred to in the Commission proposal.)
It clarifies that substance-based devices should be assessed in relation to relevant safety and performance aspects in a proportionate manner within the applicable conformity assessment procedures, while avoiding unnecessary reliance on pharmaceutical regulatory requirements not fully adapted to medical devices.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Member States where the device is or is to be made available, | 4. deleted |
It removes the administrative requirement to indicate the Member States in which a device is or will be made available due to its unclear added value for market surveillance or patient safety.
| Text proposed by the Commission | Amendment |
|---|---|
| The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged.; | The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged. These dialogues may include structured and interactive exchanges, including pre-submission consultations, throughout the conformity assessment procedure. |
| Text proposed by the Commission | Amendment |
|---|---|
| - in the case of class IIa or class IIb devices, assess the technical documentation of the representative device(s); | - in the case of class IIa or class IIb devices, assess the technical documentation of the representative device(s), while ensuring that issues already assessed are not subject to re-assessment during the conformity assessment procedure. |
Ensures that issues already resolved during the conformity assessment will not be reviewed again at a later stage of the conformity assessment.
| Text proposed by the Commission | Amendment |
|---|---|
| – leverage evidence from previous assessments performed. | – accept evidence from previous assessments performed by the same or other notified body pursuant to this Regulation. |
Recognising assessments already carried out under the MDR avoids duplication and improves predictability while ensuring safety and compliance.
| Text proposed by the Commission | Amendment |
|---|---|
| (iiia) the following indent 11a is added: ‘– assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I, focusing on the critical safety and performance elements of the device and on the sections of the technical documentation affected by design changes, post-market surveillance data or risk management updates.’ |
This amendment focuses the notified body’s assessment on critical safety and performance elements and on updated sections of the technical documentation, improving efficiency without reducing rigour.
| Text proposed by the Commission | Amendment |
|---|---|
| Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition: | Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended: |
| Text proposed by the Commission | Amendment |
|---|---|
| – in a critical situation with a risk of causing death or an irreversible deterioration of a person's state of health, in which case it is classified as class III; | – in treat or diagnose a disease or condition in a critical situation, in which case it is classified as class III; |
| Text proposed by the Commission | Amendment |
|---|---|
| – in a serious situation with a risk of causing a serious deterioration of a person's state of health or a surgical intervention, or to drive clinical management in a critical situation in which cases it is classified as class IIb; | – in treat or diagnose a disease or condition in a serious situation, or to drive clinical management of a disease or condition in a critical situation in which cases it is classified as class IIb; |
| Text proposed by the Commission | Amendment |
|---|---|
| – in a non-serious situation, or to drive clinical management in a serious situation or to inform clinical management in a critical or serious situation in which cases it is classified as class IIa.; | – in treat or diagnose a disease or condition in a non-serious situation, or to drive clinical management of a disease or condition in a serious situation, or to inform clinical management of a disease or condition in a critical or serious situation, in which case it is classified as class IIa. |
| Text proposed by the Commission | Amendment |
|---|---|
| Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed on or in the human body are classified as:; | deleted |
| Present text | Amendment |
|---|---|
| (6a) Section 7.1 is replaced by the following: | |
| All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III. | "All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has a clinically relevant ancillary action contributing to the intended medical purpose of the device, are classified as class III." |
(This amendment seeks to amend a provision within the existing act – Annex I, Section 7.1 – that was not referred to in the Commission proposal.)
Avoids disproportionate classification where the substance does not play a role in contributing to the intended medical purpose of the device.
| Present text | Amendment |
|---|---|
| (a a) Section 2.4 is replaced by the following: | |
| 2.4. The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether after those changes the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate. | "2.4. The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system or substantial changes to the device range included in the certificate, including the addition of a new product category or a new generic device group to the scope of the certificate. The notified body shall assess the proposed changes, determine whether additional audits or documentary reviews are necessary, and verify whether the quality management system continues to meet the requirements referred to in Section 2.2 after those changes. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, the conclusions of any additional audits or reviews. The approval of any substantial change to the quality management system or to the device-range covered by the certificate shall take the form of a supplement to the EU quality management system certificate." |
Clarifies that additional audits or reviews are required only where necessary, reducing unnecessary administrative burden.
| Text proposed by the Commission | Amendment |
|---|---|
| The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body shall carry out the surveillance audits and assessments only once every 24 months.; | The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the manufacturer compliance history, the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body may consider to carry out the surveillance audits and assessments only once every 24 months.; |
| Text proposed by the Commission | Amendment |
|---|---|
| The notified body shall perform short-notice or unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors when justified based on concerns related to post-market surveillance or vigilance data or at the request of a competent authority. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.; | The notified body shall perform short-notice or unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer’s suppliers or subcontractors, in accordance with a risk-based audit plan. The frequency and scope of such audits shall take into account the risk class and type of device, the manufacturer’s compliance history and relevant post-market surveillance or vigilance data. Such audits may be combined with the periodic surveillance assessment referred to in Section 3.3 or be performed in addition to that surveillance assessment. |
| Present text | Amendment |
|---|---|
| (7b) Section 5.4 is replaced by the following: | |
| 5.4 Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body | "5.4 Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body |
| (a) The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and only in respect of the requirements not covered by this Regulation, in accordance with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions. | (a) The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified, where applicable, with regard to absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances, and the potential for adverse reactions, taking into account the state of the art and the characteristics of the substance or combination of substances." |
(This amendment seeks to amend a provision within the existing act – Annex IX, Section 5.4 – that was not referred to in the Commission proposal.)
Clarifies that substance-based medical devices must be assessed with regard to the relevant safety aspects, while avoiding the automatic application of medicinal product requirements where this is not appropriate.
| Text proposed by the Commission | Amendment |
|---|---|
| Points (b) to (e) shall not apply to devices for which confirmation of safety and performance based on clinical data is not deemed appropriate in accordance with Article 61(10).; | Points (b) to (e) may not apply to devices for which confirmation of safety and performance based on clinical data is not deemed appropriate in accordance with Article 61(10).; |
| Text proposed by the Commission | Amendment |
|---|---|
| (k) For devices that are used exclusively with a medicinal product in accordance with Article 19 of [Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2011/83/EC and Directive 2009/35/EC] and packaged together with a medicinal product, the instructions for use may be included, where needed, as part of the co-packaging of the medicinal product with the device. Moreover, the information on the label of the device may be limited to the particulars referred to in Section 20.2., points (a) and (c), where, following agreement of the competent authority responsible for the authorisation of the medicinal product, the following conditions are met: | (k) For devices that are used exclusively with a medicinal product in accordance with Article 19 of [Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2011/83/EC and Directive 2009/35/EC] and packaged together with a medicinal product, where instructions for use are needed, they shall be included as part of the co-packaging of the medicinal product with the device. Moreover, the information on the label of the device may be limited to the particulars referred to in Section 20.2., points (a) and (c), where, following agreement of the competent authority responsible for the authorisation of the medicinal product, the following conditions are met: |
| Text proposed by the Commission | Amendment |
|---|---|
| a) (ja) The electronic instructions for use shall provide only the current version of the information covered by the conformity assessment and shall be protected against unauthorised modification. |
| Text proposed by the Commission | Amendment |
|---|---|
| The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body shall carry out the surveillance audits and assessments only once every 24 months.; | The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the manufacturer’s compliance history, the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body may carry out the surveillance audits and assessments once every 24 months. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3.4. The notified body shall perform audits, at short notice or unannounced, on the site of the manufacturer and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors, when justified based on concerns related to post-market surveillance or vigilance data or at the request of a competent authority. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.; | 3.4. The notified body shall perform short-notice or unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer’s suppliers or subcontractors, in accordance with a risk-based audit plan. The frequency and scope of such audits shall take into account the risk class and type of device, the manufacturer’s compliance history and relevant post-market surveillance or vigilance data. Such audits may be combined with the periodic surveillance assessment referred to in Section 3.3 or be performed in addition to that surveillance assessment. |
Back matter, 2
Parts that accompany the text rather than belong to it: explanatory statement, annexes, opinions appended by other committees. Collapsed.
Explanatory statement 10 blocks
Medical devices and in vitro diagnostic medical devices are essential components of modern healthcare systems in the Union. They support the prevention, diagnosis, monitoring and treatment of diseases and are central to ensuring high-quality patient care, improved patient outcomes and the overall resilience, sustainability and innovation capacity of healthcare systems.
Regulation (EU) 2017/745 and Regulation (EU) 2017/746 were adopted to strengthen patient safety, enhance transparency and ensure a high level of regulatory oversight. These objectives remain fully valid. However, experience with implementation has shown that the current framework also creates significant practical challenges, including increased administrative burden, lengthy and complex conformity assessment procedures, regulatory uncertainty and risks to the timely availability of certain devices on the Union market.
These challenges are particularly relevant for small and medium-sized enterprises, which constitute the backbone of the European medical technology sector. At the same time, healthcare providers and patients increasingly face difficulties in accessing niche and specialised devices, including those intended for rare diseases and highly specific clinical applications. There are also concerns that innovative technologies including breakthrough niche and orphan devices, companion diagnostics and drug-device combinations, may reach patients in the Union later than in other jurisdictions or may not become available at all.
The Commission proposal represents an important step towards addressing these challenges by seeking to simplify the regulatory framework, reduce unnecessary administrative burden and improve the efficiency of conformity assessment procedures, while maintaining the high standards of safety and performance established under the MDR and IVDR.
The amendments in this report aim to support the Commission’s objective of simplification by ensuring that it leads to tangible benefits for patients, healthcare providers and manufacturers. In particular, they seek to improve regulatory predictability and promote a more proportionate framework that facilitates innovation and the availability of medical technologies in the Union. They also seek to strengthen legal certainty around regulatory status, classification, well-established technology and the role of CE marking.
The report addresses breakthrough and orphan devices, which concern unmet medical needs, including serious conditions and rare diseases affecting small patient populations. A clearer regulatory framework including prioritised conformity assessment, rolling review where appropriate and structured early advice, may support earlier access to innovation while maintaining robust requirements for safety and clinical evidence, thereby contributing to innovation across the sector, including for SMEs and research-intensive companies.
The report also addresses the functioning of the conformity assessment system. Notified bodies play a central role in ensuring the safety and performance of medical devices, while capacity constraints and procedural delays continue to affect certification timelines. The amendments therefore aim to improve efficiency, predictability and resource use while safeguarding the integrity of the system. This includes a more risk-based and proportionate approach to surveillance activities, technical documentation assessment, sampling and periodic reviews.
Moreover, the report underlines the importance of greater legal clarity and consistent application of regulatory requirements across Member States in order to ensure uniform implementation, reduce administrative complexity and support the proper functioning of the internal market for medical technologies.
At the same time, the rapporteur emphasizes that any simplification must not come at the expense of patient safety. The MDR and IVDR were adopted to address serious shortcomings in the previous regulatory framework, and their core objectives must remain fully intact. Simplification efforts should therefore focus on reducing unnecessary duplication, improving efficiency and ensuring proportionate regulatory requirements, while maintaining robust standards for safety, clinical performance and post-market surveillance. The report therefore preserves essential safeguards, including clinical evidence requirements, benefit-risk assessment, vigilance, post-market clinical follow-up and periodic safety update reports, while allowing proportionate adjustments where justified by the risk profile of the device.
Ultimately, the objective of this report is to contribute to a regulatory framework that ensures a high level of patient safety while improving access to innovation, strengthening regulatory efficiency and supporting the continued availability of essential medical technologies in the Union. The rapporteur therefore supports a balanced revision of the MDR and IVDR that places patients at its centre, fosters innovation and ensures a predictable, efficient and resilient regulatory system for medical technologies.
Annex: declaration of input 4 blocks
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he included in his report input on matters pertaining to the subject of the file that he received, in the preparation of the draft report, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register1, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| Association of the European Self-Medication Industry |
| Becton Dickinson |
| Bio Marin Pharmaceutical |
| Bundesverband Medizintechnologie |
| COCIR |
| Deutsche Krankenhausgesellschaft e. V. |
| Edwards Lifescience |
| EFPIA |
| European Economic and Social Committee (EESC) |
| European Social Insurance Platform |
| GAIA AG |
| Pharma Deutschland |
| Radimed |
| Solventum |
| Standing Committee of European Doctors (CPME) |
| Team-NB |
| 2. Representatives of public authorities of third countries, including their diplomatic missions and embassies |
| None |
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the natural persons concerned the European Parliament’s Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.
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Sources & citation
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- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “DRAFT REPORT on the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I”. Text, 30 June 2026. docId SANT-PR-787987. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/SANT-PR-787987 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/SANT-PR-787987 (CC BY 4.0).
BibTeX
@misc{epw-text-sant-pr-787987,
author = {{European Parliament}},
title = {{DRAFT REPORT on the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I}},
year = {2026},
date = {2026-06-30},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/SANT-PR-787987}},
url = {https://news.eu-parl.st-solutions.dev/texts/SANT-PR-787987},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId SANT-PR-787987. Data: EP Open Data API: document record (CC BY 4.0)}
}