On the urgent need to revise the Medical Devices Regulation
B-10-2024-0127
on behalf of the PfE Group · Rapporteur: Ondřej Knotek, Viktória Ferenc
- Voted on · Adopted 0–0–0 · See the decision →
- Full procedure 2024/2849
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 calls on the Commission to propose a revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation to address implementation challenges.¶ The revision should consider stakeholders' views, ensure timely availability of medical technologies, make the regulatory system more predictable, reduce administrative burden for manufacturers (especially SMEs), increase competitiveness, and maintain high patient safety.¶¶¶
Key points
- Calls on the Commission to propose a revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation to address implementation challenges.¶
- Underlines that the revision should take into consideration the views of stakeholders along the entire value chain.¶
- Stresses that the revision should focus on ensuring timely availability of medical technologies, a more predictable regulatory system, and a reduction in administrative burden for manufacturers, especially SMEs.¶
- Emphasises that the revision should contribute to increasing the competitiveness of the sector while ensuring a high level of patient safety.¶
Who is affected
- Manufacturers of medical devices, especially small and medium-sized enterprises, will face reduced administrative burden.¶
- Patients will benefit from timely availability of medical technologies and maintained high safety standards.¶
- Stakeholders along the entire value chain, including notified bodies and healthcare providers, will have their views considered in the revision.¶
Legal basis: Article 5(3) of the Treaty on European Union¶