Skip to content
MOTION FOR A RESOLUTION (2024/2849(RSP))

On the urgent need to revise the Medical Devices Regulation

B-10-2024-0125

on behalf of the PPE Group · Rapporteur: Peter Liese

Official HTML ↗ PDF DOCX
✦ In shortFull text
✦ In short · AI summary of this text, generated 4 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.

This resolution calls on the Commission to propose a systematic revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation within the first hundred days of the new mandate. It demands measures to address delays, bottlenecks, and shortages, including increasing notified body capacity, abolishing re-certification for lower-risk products, harmonizing fees and procedures, and supporting SMEs. It also calls for adapting the regulations to new technologies, defining orphan devices, simplifying rules for niche products, enhancing emergency flexibility, and strengthening post-market surveillance and international cooperation.

Key points

  1. Calls on the Commission to propose a systematic revision of the MDR and IVDR within the first hundred days of the new mandate.
  2. Urges the use of Article 36(3) MDR implementing acts to resolve divergent interpretations and streamline processes, reducing bureaucratic burden without compromising patient safety.
  3. Urges Member States and the Commission to increase the speed and efficiency of notified bodies to ensure timely certification.
  4. Advocates abolishing re-certification for lower-risk products (Class IIa and certain Class IIb), implantable Class IIb and Class III devices, and IVDs after initial re-certification, subject to surveillance.
  5. Calls for transparent, harmonised maximum durations for conformity assessment steps and EU-wide harmonisation of notified bodies' fees, published in a standardised dashboard.
  6. Calls for revising PRRC qualification criteria to allow practical experience and training as alternatives to academic qualifications.
  7. Calls for amendments to accommodate new technologies, including fast-track approval for breakthrough devices and a prioritisation procedure for innovative devices.
  8. Calls for clear definitions of 'orphan device', 'orphan population' and 'orphan subpopulation' and simplified rules for niche and orphan devices, with a register and EU-wide clinical registries.
  9. Urges specific measures to support SMEs, including model documents, financial assistance, regulatory guidance, tailored certification pathways, and reduced conformity assessment costs.
  10. Calls for enhanced flexibility during public health emergencies, including temporary streamlining of certification and a list of critical medical devices.
  11. Calls for a central governance structure or medical device office within the Commission's DG Health to centralise responsibilities and coordinate market surveillance.
  12. Calls for a stronger post-market surveillance system with a centralised EU database, and for international cooperation on certification with the US FDA.

Who is affected

  • Manufacturers of medical devices and in vitro diagnostic medical devices, particularly SMEs, will face revised certification rules and reduced burdens.
  • Notified bodies will see changes in capacity, fees, and oversight, with potential centralisation of designation and surveillance.
  • Patients will benefit from improved access to innovative and orphan devices, but may face transition periods before new rules apply.
  • Healthcare providers and national authorities will be involved in post-market surveillance and coordination with a central EU office.

Figures and deadlines

  • First hundred days of the new mandate for the Commission to propose a revision.
  • Five years for initial re-certification of in-vitro diagnostic medical devices.

Legal basis: Article 168 of the Treaty on the Functioning of the European Union