What changed

Non-substantial follow-up to the European Parliament non-legislative resolution on the urgent need to revise the Medical Devices Regulation

B100127/2024

ResolutionEuropean tabledParliament pursuantresolution toon Rulesthe 136(2)urgent andneed (4)to ofrevise the European Parliament’s RulesMedical ofDevices procedureRegulation

Reference number: 2024/2849 (RSP) / RC-B10-0123/2024 / P10_TA(2024)0028

(2024/2849(RSP))

Date of adoption of the resolution: 23 October 2024

The European Parliament,

Competent Parliamentary Committee: N/A

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

Competence: Commissioner Kyriakides

– 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),

The Commission will not be responding formally to the requests addressed in the resolution as they were comprehensively addressed in plenary on 9 October 2024 by Vice-President Jourova on behalf of Commissioner Kyriakides.

– 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.