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

On the urgent need to revise the Medical Devices Regulation

B-10-2024-0124

on behalf of the Renew Group · Rapporteur: Andreas Glück

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This resolution addresses the urgent need to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), citing shortages, access inequalities, and administrative burdens. Parliament calls for more transparency from notified bodies and authorities, harmonised guidance, reduced administrative burdens, and a proper evaluation of the MDR by 2027, including examination of dependency on non-EU countries.

Key points

  1. Deplores shortages of medical devices and lack of access in parts of the EU; stresses that access and quality should not depend on location.
  2. Welcomes increased capacity of notified bodies; invites Member States and Commission to assess measures to improve speed and efficiency without jeopardising patient safety.
  3. Calls for more transparency, information and guidance from authorising authorities to manufacturers, including on notified body fees.
  4. Calls for greater transparency and better access to information for patient organisations and healthcare professionals from notified bodies and national authorities.
  5. Underlines that product updates should not necessarily require full recertification; calls for harmonised guidance for consistency across the EU.
  6. Welcomes non-legislative actions by the Commission and calls for further actions to counter shortages and reduce administrative burdens.
  7. Welcomes the European Medicines Agency pilot programme to support manufacturers and notified bodies for orphan devices.
  8. Notes that post-authorisation market surveillance can be burdensome; a more harmonised approach could benefit developers and Member States.
  9. Recalls that the MDR should be evaluated by 2027 at the latest; stresses the need for a proper evaluation and impact assessment involving all stakeholders.
  10. Believes reducing administrative burdens and ensuring access should be key considerations in the evaluation.
  11. Believes the evaluation should also examine dependency on non-EU countries, including protection of personal medical data.
  12. Emphasises that any new or changed rules must come with an appropriate transition period.

Who is affected

  • Medical device manufacturers, especially small and medium-sized enterprises, face burdensome certification processes and seek reduced administrative burdens.
  • Patients and healthcare professionals experience shortages and lack of access; they need better information from notified bodies and authorities.
  • Notified bodies are asked to improve speed and efficiency and provide more transparency on fees.
  • Member States and the Commission are invited to assess measures and take further actions to counter shortages.

Figures and deadlines

  • More than 500 000 different medical devices are marketed in the EU.
  • The MDR should be evaluated by 2027 at the latest.

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