Regulating Medical Devices in the UK

28 April 2023 – the UK MHRA published the updated guidance on regulating medical devices in the UK and EU markets.

This guidance was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023. This guidance has been updated with changes to ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.