Today, 21 October, the UK government confirmed the indefinite recognition of CE marked medical devices and IVDs in Great Britain. This decision comes a few months after a public consultation which closed in April 2026.
What does this decision mean for UK market entry?
The decision means that for the Great Britain market (England, Wales, and Scotland) the UK government does not require an additional approval route for devices already approved for the EU market. In Northern Ireland, the EU MDR and IVDR apply and the CE marking is already required for medical and in-vitro diagnostic devices. Consequently, the 2030 deadline for devices fully compliant with the EU MDR and IVDR no longer applies. A UK Responsible Person is still required to enter the market, also for CE marked medical devices and IVDs. UKCA and UKNI markings will continue to exist for UK conformity assessment routes.
Background: continuous medical devices’ access for patients across Great Britain
More than 90% of medical devices used in Great Britain bear the CE marking. The decision to accept CE-marked medical devices on a long-term basis was taken in order to maintain safe and uninterrupted access. Continued recognition of CE-marked devices goes together with MHRA’s 2030 Strategy to expand reliance and international recognition routes from trusted regulatory frameworks.
Contact us for any questions on market entry.
References:
Gov.uk (2026). Press release – Government confirms indefinite recognition of CE marked medical devices. Retrieved on 21 October 2026.
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