A statutory instrument has been laid in the UK Parliament, which will enable an extended timeframe for acceptance of CE-marked medical devices on the Great Britain market, the MHRA has announced.
Subject to Parliamentary approval this will mean that CE-marked medical devices will be accepted on the Great Britain market beyond the current deadline of 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.
The MHRA says that it is aiming for the revised framework to now apply from July 2025. In setting this timeline it has taken on board feedback from external stakeholders, such as concerns about limited capacity of conformity assessment bodies.
In March this year, the EU took 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.
The MHRA guidance has been updated to reflect these planned changes to the acceptance of CE marked medical devices in Great Britain.
