Proposal for a Regulation 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
Proposed Replacement EU Act
Date of Notification to DSC: 2 January 2026
Date proposal was first published: 16 December 2025
Status: Proposed Replacement EU Act
Departmental assessments of impact:
Evidence received (updated as received):
Department of Health - Written Answers [PDF, 4 pages, 143KB]
DSC Decisions:
At its meeting of 26 February 2026 the Committee decided to monitor the progress of the proposed replacement act and publish any interim reports it considers appropriate, pursuant to paragraph 7(1) of Schedule 6B to the Northern Ireland Act 1998.
Relevant Official Report (Hansard) transcript:
