Proposal for a Regulation - Targeted revision of the EU rules for medical devices and in vitro diagnostics

EESC opinion on the Proposal of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I  - COM(2025) 1023 final – 2025/0404 (COD) 

Background 

This initiative seeks to streamline EU rules for medical devices and in vitro diagnostic products, ensuring the availability of safe, effective and innovative technologies that uphold a high level of patient safety, public health and quality care.
Building on an evaluation of the current framework, the initiative aims to:

• strengthen the competitiveness of the EU medical device sector within the internal market and globally, fostering innovation and reducing strategic dependencies;
• ensure that safety requirements are cost-efficient, proportionate and supportive of timely access to essential medical technologies.

Practical information

Composition of the study group

Administrator in charge: Silvia STAFFA
Assistant: Alexandra SEIDENBERG

For more information please contact the INT Section Secretariat