The MHRA have drafted a Statutory Instrument (SI) amending UK MDR and removing the sunset date for four pieces of assimilated EU legislation.
Following their recent consultation, the MHRA have drafted an SI amending UK MDR to remove the sunset date for four pieces of assimilated EU legislation. This allows the current legislation to operate until such time that MHRA proposes new legislation to amend or replace these aspects as part of the proposed UK Pre Market SI.
It applies to the following four pieces of legislation:
- regulation 4H(2) (revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date)
- regulation 4J(3) (revocation of Commission Regulation (EU) No 207/2012on 26th May 2025)
- regulation 4K(4) (revocation of Regulation (EU) No 722/2012on 26th May 2025)
- regulation 4L(5) (revocation of Regulation (EU) No 920/2013on 26th May 2025 and its effect before that date).”
A link to the SI can be found here.
