On 21 October 2026, the UK government confirmed the indefinite recognition of CE-marked medical devices and IVDs in Great Britain. The decision follows a public consultation conducted earlier this year and provides manufacturers with long-term certainty for placing CE-marked products on the Great Britain market.
What does this mean for UK market access?
For the Great Britain market (England, Scotland, and Wales) manufacturers of devices already compliant with the EU MDR and IVDR will continue to be able to place their products on the market without requiring an additional UK conformity assessment route.
This decision is intended to maintain safe and uninterrupted access to medical devices across Great Britain, while reducing regulatory duplication and unnecessary burden for manufacturers.
As a result, the deadline previously set by which CE-marked medical devices and IVDs were accepted in Great Britain only until 2030 no longer applies.
The UKCA route will remain available as the domestic conformity assessment pathway.
How Obelis UK can help
While CE-mark recognition will continue indefinitely, non-UK manufacturers placing CE-marked medical devices or IVDs on the Great Britain market must still appoint a UK Responsible Person (UK RP)!
Whether you are entering the UK market for the first time or maintaining an existing product portfolio, Obelis UK Ltd. team supports you by acting as UK RP, assists with MHRA device registration requirements, and provides guidance on ongoing compliance obligations and regulatory requirements.
With the continued recognition of CE-marked devices, now is an ideal time for manufacturers to review their UK market access strategy and ensure that all regulatory obligations are met.
Do you have questions about medical devices with artificial intelligence features? Contact us today
References:
MHRA. (2026). Government confirms indefinite recognition of CE marked medical devices. Retrieved on 22 October 2026.
MDlaw. (2026). UK launches consultation on the indefinite recognition of CE-marked devices in Great Britain. Retrieved on 22 October 2026.
MDlaw. (2026). UK government confirms indefinite recognition of CE marked medical devices and IVDs. Retrieved on 22 October 2026.
Obelis UK Ltd. (2026). MHRA Device Registration. Retrieved on 22 October 2026.
Obelis UK Ltd. (2026). UK Responsible Person for Medical Devices. Retrieved on 22 October 2026.
Giorgia Peotta
Regulatory Intelligence & Innovation
26/10/2026