Current regulations provide that the acceptance of CE marked medical devices on the Great Britain market were meant to end on 30 June 2023.
A statutory instrument has subsequently been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great Britain market.
Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline (30 June 2023). This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices.
The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients. We are aiming for the revised framework to now apply from July 2025. In setting this timeline we have taken on board feedback from external stakeholders, such as concerns about limited capacity of conformity assessment bodies.
The MHRA stated in March 2023 that the EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR), including extending validity of certain CE certificates. To provide greater clarity for industry, they have published guidance about acceptance of such certificates on the Great Britain market.
The MHRA guidance has been updated to reflect these planned changes to the acceptance of CE marked medical devices in Great Britain. They will continue to work with industry, trade associations and the wider medical devices community to support the effective implementation of the new regime.
Future regulatory changes will be accompanied by further guidance to support the MedTech sector in the interpretation of the new regulatory requirements.