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

This law is a proposed replacement EU law: Article 13(3a) applies and the Stormont Brake could be used under certain circumstances. Read more about the procedure for new and amending/replacement EU laws and how they apply in Northern Ireland.

The table below sets out the main procedural steps and the Assembly’s scrutiny of this proposed act.

Category	Proposed Replacement EU Act
Procedure	Article 13(3)
Proposed EU law	COM/2025/1023 Proposal for a 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 [EXTERNAL LINK]
UK Government assessment and further information	Information considered by the Democratic Scrutiny Committee
Date of notification of proposed EU Act to the Democratic Scrutiny Committee (DSC)	02/01/2026
Decision by DSC to monitor	At its meeting of 26 February 2026, the Committee decided to monitor the progress of the proposed replacement act.
Date of publication in Official Journal of the EU 2-month scrutiny period starts	N/A
Date of notification of published EU act to the DSC	N/A
Deadline for DSC decision on an inquiry	N/A
Decision to hold an inquiry	N/A
Deadline for publication of DSC Report	N/A
DSC report	N/A
Stormont Brake notification deadline	N/A
Stormont Brake notification	N/A
UKG notification to European Commission	N/A
End of two-month scrutiny period	N/A