Great News for CE Marked Medical Device Manufacturers: MHRA Proposes Indefinite Recognition
If you manufacture or distribute CE marked medical devices and have been uncertain about the future of market access in Great Britain, today’s announcement from the MHRA should come as welcome relief.
On 16 February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on indefinite recognition of CE marked medical devices in the GB market. This is a significant shift in UK regulatory policy — and one that could reshape the landscape for thousands of medical device businesses across Europe and beyond.
What Has Been Announced?
Currently, around 90% of the medical devices used in Great Britain carry the CE mark. Since Brexit, businesses have been navigating a complex transition period, with the expectation of eventually needing to obtain a separate UKCA mark to remain on the GB market. That transition has been extended multiple times already — most recently in 2023, when the deadline was pushed to 2030.
Now, the MHRA is proposing to go much further. Instead of another deadline extension, they are consulting on making CE mark recognition permanent.
The Three Key Proposals
The MHRA’s consultation centres around three core proposals that medical device businesses should be aware of:
1. Aligning GB Timelines with the EU MDR Transition
For devices still certified under the older EU Medical Device Directive (MDD), the MHRA proposes aligning GB transition timelines with the EU’s own shift to the EU Medical Device Regulation (EU MDR). This means manufacturers won’t face a separate, conflicting deadline in GB while they’re already managing the complex EU MDR transition — reducing the risk of supply disruption on both sides.
2. Permanent Recognition of EU MDR and EU IVDR Devices
This is the headline proposal. Devices that comply with the EU Medical Device Regulation (EU MDR) or the EU In Vitro Diagnostic Regulation (EU IVDR) would be recognised indefinitely in Great Britain. For manufacturers who have invested heavily in EU MDR compliance, this means that investment automatically opens the GB market as well — no separate UKCA certification required.
3. An International Reliance Route for Higher-Risk Devices
For a small proportion of CE marked devices that fall into a higher risk classification under GB rules, the MHRA proposes an international reliance route. This would provide appropriate regulatory oversight while still ensuring these products remain accessible to UK patients and healthcare providers.
What This Means for Your Business
For medical device manufacturers — especially those already holding or working toward CE certification — this consultation represents potentially the most significant simplification of GB market access since Brexit.
Here’s what it means in practical terms:
Reduced regulatory burden. If adopted, these proposals would eliminate the need for a parallel UKCA certification process for the vast majority of medical devices. One certification — your CE mark — would serve both the EU and GB markets.
Long-term market certainty. The industry’s top request to the MHRA has been clarity on the future of CE recognition. Indefinite recognition would provide exactly that, allowing businesses to plan investments, product launches, and supply chains with confidence.
Lower costs of market entry. Removing the requirement for separate GB-specific conformity assessment means reduced costs for manufacturers, particularly small and mid-sized enterprises that may have struggled to justify dual certification expenses.
The UKCA mark isn’t disappearing — it’s being repositioned. The MHRA has signalled that the UKCA mark will be refocused as a specialist route for first-in-market innovative products, including AI-powered medical devices. This positions the UK as a potential fast-track destination for cutting-edge health technology.
What Should You Do Now?
The consultation is open from 16 February 2026 until 10 April 2026, and the MHRA is actively seeking input from manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, and patient groups.
We strongly encourage all medical device businesses to:
- Review the full consultation document on the GOV.UK website
- Submit your feedback before the 10 April deadline
- Assess your current regulatory strategy in light of these proposed changes
- Ensure your CE marking is robust and up to date, as it may become your single route to both the EU and GB market access
How Euverify Can Help
At Euverify, we specialise in helping businesses navigate the complexities of EU and UK regulatory compliance. Whether you need support with CE marking, EU MDR transition planning, GPSR compliance, or understanding how these MHRA proposals affect your specific product portfolio, our team is here to guide you.
If you’re unsure how this consultation impacts your medical devices or want help preparing a response, get in touch with us today. The regulatory landscape is evolving — and this time, it’s evolving in your favour.
Have questions about the MHRA consultation or CE marking? Contact the Euverify team for expert guidance tailored to your business.
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