On the urgent need to revise the Medical Devices Regulation

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.