MHRA Consultation on Indefinite Recognition of CE Marked Medical Devices Closes

The Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the indefinite recognition of CE marked medical devices in Great Britain has now closed. The consultation ran from 16 February 2026 and closed at 11:59pm on 10 April 2026. It sought views on how CE marked devices should be recognised in Great Britain on a long-term basis and what legislative changes may be required to support that approach.

The consultation represents an important step in the continuing development of the UK medical devices regulatory framework following Brexit.

What Was Proposed?

The consultation set out proposals that included:

• Extending existing transitional arrangements for devices compliant with the Medical Device Directive so that timelines align with EU transition provisions
• Indefinitely recognising devices that comply with the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Devices Regulation in Great Britain
• Introducing an international reliance route for devices that are classified higher in Great Britain than under EU legislation

The proposals relate to devices placed on the market in Great Britain. The regulatory position in Northern Ireland continues to operate under separate arrangements.

Why This Matters

Under current legislation, CE marked devices can continue to be placed on the Great Britain market during transitional periods that run until 30 June 2028 or 30 June 2030, depending on device type and certification pathway.

If the proposals move forward, indefinite recognition will represent a significant policy decision. For many manufacturers it could:

• Reduce duplication between CE and UKCA marking pathways
• Lower regulatory and operational costs
• Provide greater long-term certainty when planning market access strategies
• Support continued patient access to a wide range of medical technologies

Organisations will nonetheless still need to assess how the proposals interact with future UK regulatory reform and whether any conditions may be attached to ongoing recognition.

Engagement from the Sector

Although described as a targeted consultation with a relatively narrow scope, it provided an important opportunity for stakeholders to share views on the future regulatory landscape. Manufacturers, Authorised Representatives, distributors, approved bodies, healthcare professionals, and patient groups were all invited to contribute feedback. Many organisations used the consultation to highlight practical experience with the current transitional framework and to comment on the operational impact of dual regulatory pathways.

What Happens Next?

Following the closing date, the Government and MHRA will review the consultation responses and publish a formal response in due course. This will outline the conclusions reached and any proposed next steps for legislative change. The outcome will be closely watched by the MedTech sector, particularly in relation to future UK and EU regulatory alignment.

How regenold UK Can Help

We are continuing to monitor developments following the consultation and analysing the potential impact across the MedTech sector. Our regulatory and compliance specialists support clients to:

• Assess strategic implications for UK and EU market access
• Review conformity assessment and labelling strategies
• Prepare for future regulatory divergence
• Plan regulatory and commercial strategies under the evolving UK framework

We will continue to provide updates as further information is released and once the Government publishes its official response.