On 16 February 2026, the MHRA launched a targeted consultation on the long-term recognition of CE marked medical devices in Great Britain. The proposal may significantly reshape UK medical device regulation changes planned after Brexit and redefine the role of UKCA marking.
Currently, CE marked devices remain accepted in Great Britain under transitional provisions:
- MDD-compliant devices until 30 June 2028,
- MDR and IVDR-compliant devices until 30 June 2030.
After those deadlines, full UKCA conformity assessment was expected to become mandatory. However, industry feedback has consistently requested indefinite CE recognition to prevent supply disruption and regulatory duplication.
Extension of MDD transitional periods in Great Britain – supply continuity strategy
The first proposal aims to align Great Britain with updated EU transitional timelines for legacy MDD devices. In the EU, certain devices may continue to transition to MDR until 31 December 2028. Under current UK rules, acceptance ends six months earlier. This misalignment creates a risk of regulatory gaps between EU and GB market access. Extending the transitional period would:
- prevent potential shortages within the NHS,
- reduce pressure on manufacturers transitioning to MDR,
- maintain supply chain stability during regulatory migration.
From a regulatory policy perspective, this is primarily a continuity measure rather than a structural reform.
Indefinite recognition of CE marked devices under EU MDR and IVDR
The most impactful element of the consultation concerns indefinite recognition of CE marked devices in Great Britain.
MHRA is considering two options:
- Indefinite recognition for all MDR/IVDR-compliant devices.
- Recognition limited to devices classified as the same or lower risk under MDR 2002 compared to EU classification rules.
If all CE marked devices were recognised indefinitely, EU conformity assessment decisions would effectively determine access to the GB market without additional UK Approved Body review.
Manufacturers would still be required to:
- register devices with MHRA,
- comply with UK post-market surveillance (PMS) obligations,
- notify MHRA of certificate suspension or withdrawal in the EU.
However, MHRA acknowledges a structural limitation: it does not have direct access to surveillance audits, supplier assessments, or technical documentation held by EU notified bodies. This may affect response times in safety investigations involving CE marked devices placed on the Great Britain market.
The alternative model — recognising only devices classified as equal or lower risk in GB — would preserve the UK’s independent risk-based classification framework.
International reliance route for higher risk devices in the UK
For devices classified at a higher risk level under MDR 2002 than under EU MDR or IVDR, MHRA proposes an international reliance route.
This route would require a streamlined review by a UK Approved Body, including:
- confirmation of valid EU market access,
- verification of GB classification rules,
- review of PMS plans,
- assessment of available PMS data from previous years.
Instead of UKCA certification, manufacturers would receive a certificate of international reliance enabling registration with MHRA.
This model seeks to balance regulatory autonomy with reliance on EU conformity assessment, ensuring proportionate scrutiny where UK classification demands higher oversight.
Strategic impact of UK medical device regulation changes on manufacturers
If adopted, CE recognition UK 2026 could fundamentally shift regulatory strategy for medical device manufacturers operating across Europe.
Great Britain may become one of the most accessible CE-based markets globally, reducing duplication costs and administrative burden. At the same time, the long-term role of UKCA marking could diminish significantly.
Manufacturers planning regulatory strategies for 2026–2035 should closely monitor consultation outcomes, as they will directly influence:
- investment decisions related to UKCA certification,
- market access timelines,
- post-market surveillance integration strategies.
The consultation signals a pragmatic shift: safeguarding supply continuity while reconsidering the extent of regulatory divergence from the European Union.