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Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices

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Details

Publication date
16 December 2025
Author
Directorate-General for Health and Food Safety

Description

Proposal for a Regulation 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

Files

  • 16 DECEMBER 2025
md_com_2025-1023_act_en.pdf