Policy paper

EM on rules on medical devices (COM(2025)1023)

The government's summary of a proposal for a regulation on simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic devices.

• From: Department of Health and Social Care and Dr Zubir Ahmed MP
• Published: 26 March 2026

Documents

EM on rules on medical devices (COM(2025)1023)

PDF, 323 KB, 13 pages

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Details

This explanatory memorandum is about a 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.

It was submitted by Dr Zubir Ahmed MP, Parliamentary Under-Secretary of State for Health Innovation and Safety, Department for Health and Social Care.

Published 26 March 2026