The Future of Medical Device Regulation in the UK: Implementation and Implications
On 27th April, the MHRA published an update on the implementation of the future medical device regulation in the United Kingdom. It was previously communicated that CE marked medical devices could be marketed in the UK until 30th June 2023.
The MHRA now intends to extend the use of CE marked devices beyond this date. This will allow for the continued safe supply of medical devices until the implementation plan for the new regulation has been put in place, and also allows for better alignment with the EU regulation transition provisions, following their update in March.
It is however intended that core aspects of the new regulation will be made applicable from July 2025. After this date, MDR and IVDR CE marked devices cannot be placed on the UK market once those certificates have expired. Additionally, Post-Market Surveillance requirements are expected to be made applicable from mid-2024.
At present, these proposals remain subject to parliamentary approval but once approval is gained, it is intended that the legislation will be implemented by the end of June this year. Key dates under this proposal can be seen below:
* Devices self-declared (Class I medical devices and General IVDs) under the Directives can only be marketed if they have been up-classified under the regulations and now require notified body involvement. MDD or AIMDD custom-made devices can no longer be marketed.