What the MHRA’s Consultation on Indefinite Recognition of CE-Marked Medical Devices Means for Manufacturers

Earlier this month, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a targeted public consultation on the indefinite recognition of CE-marked medical devices placed on the market in Great Britain (GB). The consultation opened on 16 February 2026 and will run until 10 April 2026, giving stakeholders a limited window to shape what could be a substantial long-term shift in the regulatory landscape for medical devices in the UK.

Background: CE Marking, UKCA and Transitional Arrangements

Since Brexit, the UK has been transitioning away from automatic acceptance of EU CE marks in favour of its own UKCA mark. However, transitional arrangements have repeatedly been extended: under current rules, CE-marked devices compliant with the EU Medical Device Regulation (EU MDR) or EU IVDR continue to be accepted on the GB market until 30 June 2030 (and earlier dates for legacy directives).

This creates a critical regulatory convergence period for manufacturers who sell into both the EU and UK markets. Many medical device manufacturers currently rely on CE certification and EU Notified Body involvement as part of broader global regulatory strategies. The MHRA is now consulting on proposals that could remove the sunset date entirely allowing indefinite recognition of CE-marked devices in GB.

What are the Consultation Proposals

The consultation is structured around three core proposals, inviting yes/no responses and optional comments on each: (surveys.mhra.gov.uk)

1. Extend current transitional arrangements for devices certified under the old Medical Devices Directive (MDD) so GB aligns with updated EU transitional timelines.
2. Indefinitely recognise devices compliant with the EU MDR and EU IVDR for placement on the GB market, rather than requiring UKCA conformity once current transitional deadlines expire.
3. Introduce an international reliance route for higher-risk devices where applicable, enabling recognition of devices certified by trusted global regulators.

The most significant industry transformative element for the GB market is the second proposal: indefinite recognition of CE-marked devices. If adopted, this could mean that UK regulators would continue to accept EU conformity assessments for the long term, in essence keeping EU MDR/IVDR certification alive in GB without requiring additional UK conformity assessments or approvals.

Why This Matters to MedTech Companies

For manufacturers, distributors, and regulatory professionals, the consultation signals a potential paradigm shift in UK market access strategies:

• Reduced Regulatory Duplication: Eliminating the need for a full or even partial UKCA pathway for CE-certified devices that may significantly reduce compliance burdens  especially for small and medium enterprises with limited regulatory resources.
• Supply Chain Continuity: With approximately 90% of devices on the GB market currently bearing CE marks, indefinite recognition would help safeguard supply continuity.
• Global Competitiveness: By aligning recognition of CE marking indefinitely, the UK positions itself as a potentially more flexible and industry friendly jurisdiction, which may be attractive for manufacturers targeting multi-market launches.
• Risk and Classification Considerations: The consultation also seeks views on whether recognition should apply universally or be conditioned on alignment of risk classifications between EC and UK regimes, a nuanced question with implications for device classes and post-market requirements.

Patient Safety and Regulatory Oversight

While indefinite CE recognition could ease access and reduce cost, it raises important considerations around post-market surveillance, vigilance reporting and national oversight. The MHRA’s consultation acknowledges that any approach must continue to protect patient safety and public health, including through mechanisms that ensure effective monitoring throughout the product lifecycle.

Next Steps and Timeline

Stakeholders wishing to contribute should make their views known through the consultation survey before the deadline on 10 April 2026. Responses will inform final policy decisions and any subsequent legislative changes to the Medical Devices Regulations 2002 (as amended) that govern UK device regulation. (surveys.mhra.gov.uk)

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