A new consultation seeking views on indefinite recognition of CE-marked medical devices in Great Britain is ‘very welcome and could be a major boost to both patients and MedTech growth aims’

That’s the view of regulatory specialist Elaine Gemmell of InnoScot Health — a key partner in realising healthcare innovation ambitions for Scotland.

The Medicines and Healthcare products Regulatory Agency (MHRA) recently launched the consultation, primarily “aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies”.

CE marking indicates that a product complies with EU safety, health, and environmental protection regulations, allowing it to be legally sold throughout the European Economic Area (EEA) and Turkey.

The MHRA says that around 90% of medical devices currently used in Great Britain are CE marked, and proposals for indefinite recognition “would ensure consistent long-term supply to support the health system”.

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell said: “I believe the consultation to be an important and, in my opinion, very necessary step towards extending three-year-old arrangements and forging a closer regulatory relationship with the EU.

“Having two separate regulatory regimes remains unsustainable going forward, so indefinite recognition reduces the complexities and fragmentation which have created uncertainty for those looking to innovate, invest, and thrive.

“Indeed, if the proposals are received positively by consultees, then the resulting move could provide significant reassurance for the future and a platform for encouraging the further development of safe, innovative, patient-centred medical devices.

“It would also serve to place Great Britain on a more favourable footing, helping to ensure consistent supply of medical devices to patients and an enhanced strategic position for international growth ambitions. Our health and life sciences sectors must remain competitive in attracting innovative MedTech solutions.”

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)
• 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

Elaine added: “It is vital that Great Britain is empowered to unlock the vast innovation possibilities that can arise from the forming of international MedTech collaborations. If welcomed positively, these proposals would be central to that.

“Indefinite recognition could further pave the way for the creation of AI as a medical device that is aligned to Europe, opening up more innovation possibilities and potential growth.”

Lawrence Tallon, Chief Executive at the MHRA said: “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 MedTech sector to reduce friction and costs of doing business.”

The agency is encouraging feedback from stakeholders including medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, patient groups, and the public.

The consultation will run until 10 April 2026.