Certain EU medical device laws will not be sunsetted in Great Britain on 26th May 2025
The plan to sunset a number of EU medical device laws in Great Britain has been revised following related consultation. It had been expected that four pieces of EU legislation; European Commission Decision 2002/364, on common technical specifications for in vitro diagnostic medical devices, Regulation 207/2012, on electronic instructions for use of medical devices, Regulation 722/2012, concerning particular requirements for medical devices manufactured utilizing tissue of animal origin, and Regulation 920/2013 on the criteria for designation and supervision of approved bodies under the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC) would be “sunsetted”, i.e. cease to apply in great Britain from 26th May 2025. Following the results of a consultation process conducted by the UK MHRA it was, however, concluded that these EU laws should not now be sunsetted. They will, rather, be retained “until such time as they are replaced”.