The Medicines and Healthcare products Regulatory Agency (MHRA) will evaluate the possibility of extending recognition of CE-marked medical devices beyond the current 2030 deadline, marking a potential win for medtech companies in the European market.
The agency announced it has launched a consultation seeking feedback on the ‘indefinite recognition’ of medical devices with the European approval tag within the UK, among other tenets surrounding the marketing of medical devices in the country.
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With the formal launch of the consultation, which will run until 10 April, the MHRA is seeking views on three core changes as first outlined by the agency in July 2025. In principal, the MHRA states that the proposed adaptions are intended to protect patient access and ensure the continued supply of safe and effective medical technologies.
The foremost proposal the MHRA’s consultation seeks feedback on is the indefinite recognition of CE-marked devices that comply with the EU’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) in the UK. This proposal builds on a 2023 framework established by the MHRA to recognise CE-marked medical devices on the UK market up to 2030.
According to the MHRA, this action would ensure continued patient access to essential medical devices, while being delivered alongside a domestic route to market focused on support for innovation, with the net effect of helping the UK achieve its goal of becoming a leading country for medtech access by 2030. More broadly, the proposal would align with the Life Sciences Sector Plan to drive growth, innovation, and better health outcomes in the UK, and the UK Labour government’s 10-year plan for the UK National Health Service (NHS).
The Association of British HealthTech Industries (ABHI) welcomed the news, stating: “ABHI has consistently called for continued CE recognition, so we welcome this practical step. Around 90% of devices registered for the GB market are CE marked, meaning this proposal supports patient access, provides confidence for industry, and strengthens UK competitiveness.”
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By GlobalDataThe MHRA also seeks feedback on extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the European Union’s timelines for devices to transition from the MDD to the revised EU Medical Device Regulation (EU MDR).
The EU MDR’s implementation date was recently extended through 2028 to give those in scope more time to prepare.
Finally, the MHRA proposes introducing an international reliance route for devices classified as higher risk in the UK than in the EU.
Of these proposed changes, the MHRA previously asserted that the measures would help to boost growth in the UK medical device sector by lowering manufacturers’ duplicative regulatory expenses.
The Centre for Process Innovation (CPI), a British technology and innovation social enterprise, has previously called on policy makers, investors, and healthcare leaders to unlock the full potential of the country’s medtech sector. According to recent research by the group, UK-based medtech innovators say they face too many barriers with funding and regulatory hurdles.
MHRA CEO Lawrence Tallon said: “The number one request that the medtech 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 medtech sector to reduce friction and costs of doing business.”
Tallon added that plans to “reposition” the UK Conformity Assessed (UKCA) marking as a specialist route for first-in-market innovative products, including AI as a medical device, will be further informed by findings from a report by advisory body the National Commission into the Regulation of AI in Healthcare that is due to be issued over the summer.
