EU Slaps Extension on Medical Device Deadlines to Avoid Shortages
The European Union has just given manufacturers a lifeline, pushing back key deadlines for certifying medical devices under the tough new EU Medical Devices Regulation (EU MDR). This move recognises the bottlenecks in certification bodies struggling to keep up.
Big Extension for High-Risk Devices
The transitional period for higher-risk medical gadgets like pacemakers (class III and some class IIb implantables) now runs until 31 December 2027. But there’s a catch — companies must still meet post-market surveillance standards, maintain quality management, and stay engaged with notified bodies.
Longer Breathing Space for Medium and Low-Risk Gear
For medium and low-risk devices—think syringes and other class IIb, IIa, Im, Is, and Ir items—the deadline stretches even further, to 31 December 2028. Same conditions apply: keep up surveillance, quality systems, and communication with authorities.
What This Means for Northern Ireland and Beyond
- These extensions automatically apply in Northern Ireland under the Northern Ireland Protocol.
- The validity of certificates issued since May 2017 under earlier directives has also been extended to these new deadlines.
- Certificates that expired before 20 March 2023 may stay valid if they meet certain conditions.
- Certificates set to expire after 19 March 2023 will now last until the extended deadlines.
- Extended certificates remain valid for placing CE marked devices on the Great Britain market.
The MHRA will update its registration guidance shortly to reflect these changes.
Patient Safety and Industry Relief
“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 on the market,” said Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer.
“We know the industry has been worried about certificate expiry. We’ve granted exceptional use authorisations where needed for public health, and now the EU’s renewed deadlines mean many manufacturers can supply the UK without extra hoops.”
