Skip to content
DRAFT OPINION (COM(2025)1023 – C100360/2025 – 2025/0404(COD))

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

IMCO-PA-789887

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

Official HTML ↗ PDF DOCX
✦ In shortFull text
✦ In short · AI summary of this text, generated 26 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

The Internal Market Committee's draft opinion responds to the Commission's proposal to simplify the rules on medical devices and in vitro diagnostic medical devices. It backs lighter certification and fee rules but opposes moving these devices from Section A to Section B of the AI Act's Annex I. It proposes certificates valid up to five years on first certification, then unlimited validity after a positive re-assessment, and keeps unannounced audits at least once every five years. It introduces fee reductions for micro and small enterprises and for orphan and breakthrough devices, and requires safety summaries to be patient-friendly and public on Eudamed. The amendments also cover online sales information, language rules, liability and financial coverage, shortage reporting, regulatory sandboxes and evaluation of the rules' impact on smaller companies.

Committee position. The rapporteur welcomes the Commission's simplification proposal but seeks amendments: certificates valid up to five years then unlimited after re-assessment, kept unannounced audits, fee reductions for micro, small and orphan device manufacturers, patient-friendly safety summaries, and deletion of the move of medical devices to Section B of the AI Act's Annex I.

Key points

  1. The draft opinion welcomes the Commission's aim to make the medical device framework more efficient and less burdensome, especially for SMEs, specialised manufacturers and producers of orphan and breakthrough devices, while keeping patient and consumer safety high.
  2. On first certification, certificates would be valid for up to five years, followed by a re-assessment; after a positive re-assessment, validity would not be limited in time unless the notified body considers it necessary on duly justified grounds.
  3. Unannounced or short-notice audits would be kept, to be conducted at least once every five years, and may be conducted remotely instead of on-site on justified grounds.
  4. The rapporteur opposes moving the medical device and in vitro diagnostic regulations from Section A to Section B of Annex I to the AI Act, and the amendment deletes that change.
  5. Notified bodies would apply at least a 50% annual fee reduction for micro enterprises and at least 25% for small enterprises, and at least 50% for orphan devices; micro-enterprise notified bodies would be exempt.
  6. Safety and clinical performance summaries would be written in lay language, clear to patients, and made publicly available on Eudamed.
  7. Information requirements for distance sales would be strengthened, complementing obligations under the Digital Services Act and the General Product Safety Regulation, and Member States could order providers of diagnostic or therapeutic services to cease activity on public health grounds.
  8. Member States should consider accepting information additionally in other Union languages commonly understood in the medical field, especially for devices intended for professional users.
  9. Manufacturers would have to provide sufficient financial coverage for potential liability under Directive (EU) 2024/2853, proportionate to risk class, device type and enterprise size.
  10. The EMA, with the MDSSG, would draw up and publish a list of devices whose supply interruption could seriously harm patients; consultation of the MDCG, manufacturers, supply chain actors, healthcare professionals, patients and consumers would be mandatory.
  11. Member States would publish and regularly update a public database on actual and expected supply interruptions or discontinuations of devices assessed by their competent authority.
  12. Regulatory sandboxes would be allowed only with temporary adaptation of requirements, not waiver, with participant rights and safety protected, close monitoring, and an annual public report with a lay summary on Eudamed.

Who is affected

  • Manufacturers of medical devices and in vitro diagnostic medical devices, especially micro, small and medium-sized enterprises, face changed certification, fee and reporting rules.
  • Notified bodies must apply fee reductions, conduct periodic reviews and re-certification, and keep documented procedures.
  • Producers of orphan and breakthrough devices benefit from fee reductions and targeted re-assessment.
  • Health institutions that manufacture and use devices in-house face conditions on transfer and a maximum five-year continued use period.
  • Providers of online marketplaces and intermediary services, and providers of diagnostic or therapeutic services, face strengthened information duties and possible cessation orders.

Figures and deadlines

  • Up to five years: initial validity period of certificates on first certification.
  • At least once every five years: frequency of unannounced or short-notice audits.
  • 50%: minimum annual fee reduction for micro enterprises and for orphan devices.
  • 25%: minimum annual fee reduction for small enterprises.
  • 5 years: maximum period a health institution may continue to manufacture and use its device after the target group's needs can be met on the market.
  • 20 days: time for notified bodies to inform a manufacturer about a request for conformity assessment activities.
  • At least every 3 years: frequency for manufacturers of class IIa devices to update the PSUR.
  • Five years after the date of application: earliest date for the Commission's evaluation of the regulation.