The Government’s consultation confirms that CE recognition for medical devices is here to stay, but the future role UKCA-marking will play remains open.

How did we get here?

Before Brexit, medical devices carrying a CE mark could be sold across the EU and UK under a single certification. After Brexit, the UK introduced the UKCA route as Great Britain’s domestic framework. As a post-Brexit leniency, CE-marked medical devices (conformity assessed under current EU legislation) continued to be recognised on the Great Britain market without a separate domestic assessment. That recognition, however, was intended to be temporary. 

In previous articles, Post-Brexit plot twist: UKCA-mark no more? and Beyond Brexit: CE-marking recognition amplified, our team looked at the move towards continued CE-mark recognition across a broad range of products, but medical devices were a notable exception. They were subject to their own transitional arrangements, with deadlines depending on which EU regulation underpins the certification: 30 June 2028 for devices approved under the EU Medical Devices Directive (“EU MDD”); 30 June 2030 (or earlier certificate expiry) for devices compliant with the EU In Vitro Diagnostic Directive (“EU IVDD”); 30 June 2030 for those certified under the (new) EU Medical Devices Regulation (“EU MDR”) and EU In Vitro Diagnostic Regulation (“EU IVDR”).

The consultation, which was launched on 16 February 2026, asked whether CE recognition should be made permanent instead. On 21 October 2026, the Government confirmed that it now intends to indefinitely recognise CE-marked medical devices and in vitro diagnostic devices (“IVDs”) in Great Britain, subject to parliamentary approval.

Given that more than 90% of medical devices registered for use in Great Britain carry a CE-mark, expiry of CE recognition would affect whether manufacturers continue to supply particular products, how they allocate regulatory budgets and when they launch new technologies. Indefinite recognition would help ensure Great Britain remains an attractive market for those already EU certified. For patients, this would also maintain continuity of supply and support ongoing access to safe and effective devices.

What did the consultation say?

The targeted consultation closed on 10 April 2026 and received 1,056 responses. The Government’s response deals with three issues.

Extending the deadline for legacy devices

Great Britain’s recognition of eligible devices under the EU MDD currently ends before the EU transition period closes on 31 December 2028. The Government intends to align the two deadlines to avoid a six-month gap in which devices could remain available in the EU but lose access to Great Britain. Existing eligibility requirements will be maintained, so the extension does not amount to a relaxation of the conditions a device must meet.

The response also confirms that EU MDD-certified devices placed compliantly on the EU or Great Britain market before the transition period ends are intended to remain available in Great Britain thereafter. For manufacturers and distributors, this makes the distinction between first placing a device on the market and continuing to supply existing stock particularly important, as only the former is subject to the transition deadline.

Indefinite recognition for devices under the newer EU regulations 

The Government intends to recognise all CE-marked devices certified under the EU MDR and EU IVDR indefinitely, while maintaining existing domestic requirements. 

No separate route based on device classification 

The consultation also considered limiting direct recognition to devices classified the same or lower risk in Great Britain than in the EU, with a separate international reliance route for devices classified higher risk in Great Britain. The Government will not go ahead with this, finding the additional regulatory complexity disproportionate to any safety benefit. For affected manufacturers, this avoids an extra market-access step where Great Britain and EU classifications diverge.

Less duplication does not mean less accountability

Although most respondents favoured the transitional extension and broad indefinite recognition, concerns were raised about oversight, scrutiny of post-market reports and accountability without UK approved body involvement. The response specifically acknowledges representations from patients harmed by pelvic mesh, most of whom opposed the proposals. The question the Government had to answer was therefore not only how to preserve supply, but whether continued recognition is compatible with effective patient protection.

The Government’s response is that a separate GB conformity assessment is no longer required to avoid duplicate assessment, but other UK-specific checks and obligations remain. The MHRA retains powers to issue compliance, suspension, safety and information notices. Manufacturers must continue to: register devices with the MHRA; appoint a UK Responsible Person if based outside the UK; comply with Great Britain post-market surveillance requirements, including the strengthened requirements introduced in June 2025; and meet English-language documentation requirements.

The opposition is understandable, and the safety concerns raised are not unfounded. A separate domestic assessment might have allowed the UK to develop its own requirements, but it would also have created a material barrier to market entry. The EU market is substantially larger than Great Britain’s, and for manufacturers already holding EU certification, a UK-specific assessment represents an additional cost that may tip the calculation against UK supply of some products altogether. Indefinite recognition removes that risk, while the domestic obligations described above ensure it does not become a gap in oversight. In the Life Sciences Sector Plan, the Government has set an ambition for the UK to be one of the top three fastest countries in Europe for access to MedTech by 2030; a separate assessment requirement could work against this. 

There remains a tension that the response does not fully resolve. Indefinite recognition means Great Britain’s framework will continue to track EU regulatory decisions without any domestic input, leaving the UK with limited control over the standards governing its own market. That is a pragmatic choice, though one that challenges the broader ambition for a distinct UK regulatory identity.

Where does this leave UKCA?

UKCA remains available as a domestic route to the Great Britain market. The MHRA is progressing a pre-market statutory instrument to modernise its requirements, and the Government plans to seek enabling powers for a future licensing approach. For manufacturers already certified under EU rules, pursuing a separate domestic assessment will require a clear commercial rationale.

The domestic route’s appeal may increasingly depend on whether it offers something the CE pathway does not, making the design of the wider reforms more important. Flexibility, predictability and a workable approach to emerging technologies could prove decisive, and ultimately determine whether UKCA becomes a credible alternative to CE rather than a parallel burden.

Our recent article, The UK’s blueprint for regulating AI in healthcare: what you need to know, looked at proposals for more flexible access routes alongside stronger lifecycle monitoring and accountability. For software and AI developers, those reforms may become an important factor when choosing a regulatory pathway. This is particularly relevant given that software and AI qualifying as medical devices in the EU may also be subject to the EU AI Act, which does not form part of Great Britain’s domestic regulatory framework. CE recognition offers continuity now; the wider reforms will determine what the domestic route offers in future.

Next steps

Businesses should review their product portfolios to understand which products rely on the EU MDD transitional arrangements and which are certified under the EU MDR or EU IVDR, and check that the relevant eligibility conditions are met. Continued CE recognition may also affect the commercial case for pursuing UKCA certification in parallel, including planned assessment costs, contractual arrangements and launch strategies.

Existing UK requirements, including those relating to MHRA registration, UK Responsible Persons and post-market obligations, will continue to apply, so businesses should ensure that their supply arrangements support appropriate safety reporting and access to relevant information. Northern Ireland should also be considered separately, as its regulatory framework remains distinct from that in Great Britain.

Finally, the response sets out a policy commitment rather than the implementing legislation. Subject to parliamentary approval, the MHRA intends to introduce the changes before the earliest transition period ends on 30 June 2028, so businesses should keep the final provisions and wider UKCA reforms under review.

Conclusion

The decision is more than just another extension to a Brexit deadline. It signals that CE recognition is intended to be a lasting route to the Great Britain market, with the domestic route developing alongside it. For manufacturers, this represents an opportunity to rethink where separate certification adds value. For the Government, the next task is to make the domestic route an attractive alternative, while ensuring that simpler market access is matched by effective oversight and patient protection.

If you have any questions about how these changes may affect your products, or would like to discuss your Great Britain market access or UKCA strategy, please get in touch with our team. Bird & Bird’s Life Sciences and Technology practice has extensive experience advising medical device, IVD and digital health manufacturers on regulatory, market access and commercial matters in the UK and internationally.