MHRA Consultation on Indefinite Recognition of CE-Marked Medical Devices

Detected February 17th, 2026

Summary

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks feedback on extending current transitional arrangements and introducing an international reliance route to ensure continued supply and patient access to medical technologies. The deadline for feedback is April 10, 2026.

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What changed

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has initiated a public consultation regarding proposals for the indefinite recognition of CE-marked medical devices. This move aims to protect patient access and ensure the consistent supply of safe and effective medical technologies, as approximately 90% of devices currently used in Great Britain are CE marked. Key proposals include extending transitional arrangements for EU Medical Device Directive (MDD) certified devices, indefinite recognition of EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU IVDR) compliant devices, and introducing an international reliance route for certain higher-risk CE-marked devices. The consultation is open until April 10, 2026.

This consultation is critical for medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, and patient groups. The proposals are designed to provide long-term certainty for the med tech industry, reduce friction and costs, and ensure continued patient access to essential medical devices. Companies should review the proposals and submit feedback by the April 10, 2026 deadline. The MHRA intends to reposition UKCA as a specialist route for innovative, first-in-market products, including AI as a medical device, and will continue to strengthen post-market surveillance and information sharing with EU partners.

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News story

MHRA launches a consultation on indefinite recognition of CE-marked medical devices

From: Medicines and Healthcare products Regulatory Agency Published 16 February 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a consultation on proposals for indefinite recognition of CE-marked medical devices in Great Britain (GB), aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies.

Around 90% of medical devices currently used in Great Britain are CE marked, and the proposals for indefinite recognition would ensure consistent long-term supply to support the health system. The consultation seeks feedback on the proposals to extend arrangements put in place in 2023 to recognise CE marked devices, and forms part of the MHRA’s wider programme of regulatory reform of medical devices, designed to be risk-proportionate, pro-innovation and patient-focused.

The consultation seeks views on three key proposals:

Extending current transitional arrangements for devices certified under the EU Medical Device Directive (MDD), aligning GB timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR), to minimise the risk of supply disruption.
Indefinite recognition of EU MDR and EU IVDR-compliant devices, to reduce the risk of interruption to the supply of medical devices for patients in GB.
Introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, to ensure appropriate oversight while maintaining access. These proposals for indefinite recognition of CE marked devices would ensure continued patient access to essential medical devices and would be delivered alongside a domestic route to market focused on support for innovation, helping the UK achieve its goal of becoming a leading country for MedTech access by 2030, and aligned with the Life Sciences Sector Plan.

Lawrence Tallon, Chief Executive at the MHRA said:

“The number one request that the med tech industry made of us was to provide long term certainty over CE recognition. It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the med tech sector to reduce friction and costs of doing business. We have listened carefully and acted on this clear and consistent feedback, which is why we are now pleased to consult on these proposals for indefinite recognition of CE marked medical devices.

“In addition, we will re-position UKCA as a specialist route for first-in-market innovative products, including AI as a medical device. This will be informed by the findings of the National Commission into the Regulation of AI in Healthcare which will report this summer.”

The proposals align with wider government policy for other manufactured goods sectors where continued recognition of CE marked goods has been agreed. Alongside these measures, the MHRA will continue to strengthen post-market surveillance and work to improve information sharing with EU partners, ensuring patient safety remains paramount.

The MHRA is encouraging feedback from a wide range of stakeholders, including medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, patient groups and the public, to ensure the proposals deliver the best outcomes for patients and the health system.

These proposals align with the government’s ambitions set out in the Life Sciences Sector Plan and the 10-Year Health Plan, supporting innovation, growth and patient access across the UK’s health tech sector.

The consultation opens on 16 February 2026 and will run until 10 April 2026.