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resolution motion, 16 October 2024

On the urgent need to revise the Medical Devices Regulation

Motion B-10-2024-0127 · (2024/2849(RSP))

on behalf of the PfE Group · Rapporteur: Ondřej Knotek, Viktória Ferenc

On Parliament’s site PDF Word

AI:In short

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

  1. 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.
  2. Underlines that the revision should take into consideration the views of stakeholders along the entire value chain.
  3. 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.
  4. 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

Written by AI from the full text · every figure comes from the text · ¶ opens the paragraph · 4 Sept 2026 · Report a problem

Full text

Text 16 paragraphs

B100127/2024

European Parliament resolution on the urgent need to revise the Medical Devices Regulation

(2024/2849(RSP))

The European Parliament,

–having regard to Article 5(3) of the Treaty on European Union,

–having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (the Medical Devices Regulation),

–having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (the In Vitro Diagnostic Medical Devices Regulation),

–having regard to Rule 136(2) of its Rules of Procedure,

A.whereas public health is and should remain primarily a competence of the Member States;

B.whereas the implementation of the Medical Devices Regulation has triggered many challenges for manufacturers, notified bodies and healthcare providers;

C.whereas the current complex and costly regulatory framework jeopardises the availability and affordability of medical devices for patients;

1.Calls on the Commission to propose a revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation to address the challenges that have emerged in their implementation;

2.Underlines that the revision of these regulations should take into consideration the views of the stakeholders along the entire value chain;

3.Stresses that this revision should focus on ensuring the timely availability of medical technologies, a more predictable regulatory system and a reduction in the administrative burden for manufacturers, especially small and medium-sized enterprises;

4.Emphasises that this revision should also contribute to increasing the competitiveness of the sector, while ensuring a high level of patient safety;

5.Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.