The EU has extended cert expiry dates under its 2023 Medical Device Regulation (MDR) amendments. This move offers a lifeline for device makers scrambling to meet new rules.
Key Certificate Extensions Announced
- Certificates set to expire after 19 March 2023 now last until the end of the relevant transition period.
- Extensions apply automatically in Northern Ireland.
- Extended certificates remain valid for placing CE-marked devices on the Great Britain market.
MHRA Welcomes EU’s Practical Move
Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer, said:
“Our priority is ensuring that patients have safe access to medical devices, and we welcome these changes which will help mitigate the risk of shortages of medical devices available on the market.”
“We know the medical device industry had concerns over certificate expiry. We’ve been working with them to grant exceptional use authorisations when public health needed it. These EU changes mean many manufacturers can now supply the UK without those special permissions.”
What Next?
The MHRA will update its registration guidance soon to reflect the new EU certificate extension rules, ensuring continued smooth access to vital medical devices across the UK.
