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

On the urgent need to revise the Medical Devices Regulation

B-10-2024-0123

on behalf of the S&D Group · Rapporteur: Tiemo Wölken

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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 addresses the urgent need to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). It calls for action to improve implementation, harmonise procedures, and ensure patient safety. Parliament regrets the implementation so far and the repeated extensions of transitional deadlines, and urges the Commission to facilitate implementation through delegated powers and tertiary legislation. It calls for binding harmonised timelines for certification, a coherent fee structure for notified bodies, and evaluation of recertification for low-risk devices. It also calls for specific provisions for orphan and paediatric devices, continuous monitoring of device availability, and adequate human resources in notified bodies and the Commission. Any review should be based on a comprehensive evaluation and impact assessment, but the Commission should continue using its powers in the meantime.

Key points

  1. Reaffirms commitment to the core objective of the review: ensuring patient safety through higher quality and safety standards for medical devices.
  2. Regrets the implementation of the MDR and IVDR frameworks and the repeated need for urgent procedures to extend transitional deadlines; calls for an enduring solution.
  3. Welcomes that notified body capacity for the MDR has reached 50, and encourages further coordination and harmonisation of procedures.
  4. Concerned that only 13 notified bodies are designated under the IVDR and considers this should be increased.
  5. Reiterates the call for a careful and thorough review of the regulatory framework based on the needs of patients and clinicians.
  6. Urges the Commission to act without delay to facilitate implementation through delegated powers and tertiary legislation to avoid administrative burdens.
  7. Calls for clear, binding, harmonised and predictable timelines and evidence requirements for conformity assessment and certification, including clock stops.
  8. Calls for investigating a coherent and transparent fee structure for notified bodies, considering different classes and devices for very small patient groups.
  9. Calls for evaluating the need for recertification of low-risk, non-invasive, everyday devices (class I) and providing harmonised guidance.
  10. Strongly calls for evaluating the inclusion of specific provisions for orphan and paediatric devices.
  11. Calls for continuous monitoring of device availability, particularly last remaining devices, and full development of EUDAMED.
  12. Stresses that any review should be based on a comprehensive evaluation and impact assessment, and encourages the Commission to continue using its powers in the meantime.

Who is affected

  • Manufacturers of medical devices and in vitro diagnostic medical devices, who face certification delays and unpredictability.
  • Notified bodies, which need adequate human resources and harmonised procedures.
  • Patients, who may face lack of availability of necessary devices and disparities in access.
  • Small and medium-sized enterprises and start-ups, which need better support to bring innovative products to market.
  • Producers of orphan, paediatric, and rare condition devices, which need targeted solutions.

Figures and deadlines

  • 50 notified bodies for the MDR, considered an optimal level.
  • 13 notified bodies designated under the IVDR, which should be increased.

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