Members urged to respond to MHRA consultation on indefinite CE recognition

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a targeted consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain (GB). The consultation seeks views on measures intended to protect patient access and ensure the continued supply of safe and effective medical technologies.

For BHTA medical device manufacturer members, this consultation is significant. The outcome will shape the long-term regulatory framework for CE-marked devices in GB, with implications for market access, certification planning and regulatory strategy. This is a key opportunity for members to help inform the final approach.

What is being proposed?

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.

The MHRA has stated that indefinite recognition of CE-marked devices would help ensure continued patient access to essential medical technologies, while being delivered alongside a domestic route to market focused on supporting innovation.

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.”

The proposals extend arrangements first introduced in 2023 to recognise CE-marked devices on the GB market and form part of the MHRA’s wider programme of medical device regulatory reform. They also 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 has confirmed that it will continue to strengthen post-market surveillance and improve information sharing with EU partners.

For members supplying CE-marked devices in GB, the consultation represents an important opportunity to provide practical feedback on how the proposed approach would operate in practice and to highlight any potential unintended consequences.

Respond to the MHRA consultation.

The consultation closes on 10 April 2026.