On 21 October 2026, the UK Government confirmed that it will make the unilateral recognition of EU CE marks for medical devices and in vitro diagnostic devices (IVDs) in Great Britain indefinite. The confirmation is set out in the Government’s response to the consultation it ran earlier in the year on its proposals for indefinite recognition of EU CE marks (please see our previous blog post here).
Background
Since the withdrawal of the UK from the EU (and end of the Brexit transition period), the medical devices regulatory framework in Great Britain has unilaterally recognised EU CE marks. This allows devices and IVDs validly affixed with the EU CE mark to be placed on the market or put into service in Great Britain without being subject to additional pre-market assessments. This runs in parallel to the Great Britain-specific pre-market assessment route which results in the UKCA mark.
Given that manufacturers require a CE mark to place devices and IVDs on the (much larger) EU market, the EU CE mark has continued to be the principal basis for placing devices on the market in Great Britain. The Government’s own figures indicate that over 90% of devices registered for supply in Great Britain currently carry an EU CE mark.
While the statutory unilateral recognition provisions were expressed to be time-limited, it had long been expected that the UK Government would eventually accept indefinite unilateral recognition of EU CE marks under the EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR). Following an earlier consultation on routes to market for medical devices and IVDs, in July 2025 the Government reported that a recurring theme in the consultation responses was the request to indefinitely extend the recognition of CE marked medical devices and IVDs in order to deliver uninterrupted market access to devices for patients. The Government therefore announced that it intended to consult further on proposals for CE marked devices.
What unilateral provisions will the UK Government implement?
The Government has confirmed that it will implement the following proposals from the consultation:
- Indefinite recognition of MDR and IVDR EU CE marks as a basis for placing devices on the market, or putting them into service, in Great Britain.
- Aligning the time-limits for unilateral recognition for devices CE marked under the old EU Medical Devices Directive 1993/42 (MDD) and which are compliant with the transitional provisions under the MDR, with the transitional periods under the MDR. This means that unilateral recognition for such devices will be extended up to 31 December 2028.
The Government confirmed that it will not move forward with a third proposal in the consultation, which was to introduce a separate “international reliance” route for devices classified higher in Great Britain than in the EU. The Government considered that this would introduce an unnecessary regulatory burden.
Next Steps and Conclusion
The Government will need to introduce legislation to amend the existing statutory provisions on unilateral recognition.
The indefinite unilateral recognition of EU will ensure that manufacturers that have CE marked their devices and IVDs in the EU do not need to undertake further pre-market checks when supplying the products to Great Britain. Manufacturers will need to comply with certain Great Britain-specific requirements such as registration, UK Responsible Person appointments (where applicable) and Post-Market Surveillance requirements.
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