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MOTION FOR A RESOLUTION (2024/2849(RSP))

On the urgent need to revise the Medical Devices Regulation

B-10-2024-0126

on behalf of the Verts/ALE Group · Rapporteur: Ignazio Roberto Marino

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✦ 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.

Parliament stresses support for swift implementation of the Medical Devices Regulation and In Vitro Medical Devices Regulation, and urges action to prevent device shortages, improve transparency, and strengthen post-market surveillance. It calls for a comprehensive EUDAMED database, harmonised notified body decisions, specific conformity assessment timelines, and incentives for orphan devices with clear criteria. It urges evaluation and impact assessment before any revision, with stakeholder involvement and high patient safety standards.

Key points

  1. Stresses continued support for swift implementation of the MDR and IVDR, ensuring patient safety and equal access to quality devices across the EU.
  2. Regrets continuing risks of device shortages, especially for paediatric and orphan diseases, due to suboptimal implementation.
  3. Calls for transparent supply chains, closer cooperation, and stricter reporting obligations to prevent shortages, including via the MDCG and Executive Steering Group.
  4. Demands public access to notified body certification processes and decisions, and a swift roll-out of a comprehensive, functional EUDAMED database.
  5. Urges coordinated approach and harmonisation to improve efficiency, predictability, and fee structure of notified bodies.
  6. Calls on the Commission to propose specific conformity assessment timeframes per device class, with accelerated timelines for health emergencies or high unmet need.
  7. Reiterates that orphan device incentives must have clear eligibility criteria, prevent artificial orphanisation, and be centrally registered.
  8. Calls for optimal stakeholder involvement and access to documents and decisions for patients and healthcare professionals.
  9. Calls for tertiary legislation to harmonise provisions so product updates do not always require full re-certification.
  10. Calls on manufacturers to coordinate with national authorities and prioritise patient safety by meeting MDR and IVDR requirements without delay.
  11. Urges national authorities to strengthen post-market surveillance, communicate risks to patients and public, and enforce strict timelines for corrective actions.
  12. Reiterates need for thorough evaluation and impact assessment before reopening the regulations, involving all stakeholders.

Who is affected

  • Manufacturers of medical devices: must coordinate with national authorities, meet MDR/IVDR requirements, and ensure robust evidence.
  • Notified bodies: need to improve consistency, transparency, and capacity; decisions and processes must be public.
  • National competent authorities: must strengthen post-market surveillance and enforce corrective action timelines.
  • Patients and healthcare professionals: should have access to relevant documents and decisions, and be informed of risks.

Figures and deadlines

  • Approximately 500 000 different medical devices are available on the EU market.

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