Baroness Merron and her team have successfully steered through The Medical Devices (Amendment) (Great Britain) Regulations 2025. This addresses the four pieces of EU legislation that supported the UK MDR 2002, which were due to sunset on 25th and 26th May 2025. This allows business as usual until the MHRA and DHSC can incorporate future updates into future UK, to align with the wider updates proposed for the UK MDR 2002 (as amended).
The four pieces of legislation covered:
- EU Implementing legislation regarding the designation of UK Approved Bodies to conduct conformity Assessment – EUR-Lex – 02013R0920-20200519 – EN – EUR-Lex
- EU Implementing legislation regarding electronic IFU’s (For medical devices – not for IVDs). Regulation – 207/2012 – EN – EUR-Lex – Note that for GB this law is not replaced by the updated legislation Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices Implementing regulation – 2021/2226 – EN – EUR-Lex, however this does apply to Northern Ireland.
- EU Implementing legislation regarding medical devices using tissues of animal origin – Regulation – 722/2012 – EN – EUR-Lex
- EU Implementing legislation regarding IVD Common Specifications – EUR-Lex – 02002D0364-20200702 – EN – EUR-Lex – Note that it does not bring the legislation up to the current EU version issued 02/03/2021. For GB the version remains at the version that was published prior to the UK leaving the EU 1st Jan 2021 i.e the 02/07/2020 version. For Northern Ireland the current versions applies.
