In a significant regulatory development, on 21 October 2026 the UK Government confirmed that CE-marked medical devices will be recognised indefinitely in Great Britain, providing greater certainty for medical device suppliers in the GB market.
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) officially confirmed the long-term recognition of CE-marked medical devices in Great Britain.
- This ensures that medical devices carrying the CE mark can continue to be used and trusted across the UK healthcare system, avoiding regulatory delays for patient care.
A statement from the ABHI
“Regulatory predictability and avoiding unnecessary duplication are fundamental to industry investment decisions, which ultimately determine how quickly patients can access new technologies. Long-term recognition of CE marking is therefore a significant and welcome decision, providing much-needed certainty for manufacturers, safeguarding patient access and strengthening the UK’s position as an attractive and competitive market for HealthTech.
We look forward to its implementation, with this practical and proportionate approach supporting continuity of supply and ensuring friction-free access to the medical devices, IVDs and digital health technologies on which UK patients, citizens and the NHS rely.”
Steve Lee, Executive Director, Regulation, ABHI