The Medicines and Healthcare products Regulatory Agency (MHRA) has revealed a record number of device trial approvals in the UK in 2025.
During the year, the MHRA approved 17% more clinical investigations compared with 2024, while the agency met all of its statutory 60-day deadlines for clinical investigation applications, with the average approval time standing at 51 days.
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This uptick in MHRA activity comes amid the UK government’s efforts to enhance the competitiveness of the nation’s life science industry through multiple initiatives, including The National Healthtech Access Programme and the 10 Year Life Sciences Sector Plan.
Within medtech specifically, the agency is also trialling a pilot scheme, which aims to lower barriers to growth for small, UK-based enterprises by granting application fee exemptions. The initiative, which will run until 31 March 2026, will see the MHRA award ten waivers to companies developing Class I, IIa or IIb medical devices.
According to the MHRA’s chief executive, Lawrence Tallon, the agency’s focus lies in “backing the most innovative ideas, cutting unnecessary barriers and helping companies move quickly,” especially in areas like brain health and artificial intelligence (AI).
In a 19 February statement, Steve Lee, director of diagnostics and digital regulation at the Association of British HealthTech Industries (ABHI), welcomed the MHRA’s step-up in medical device evaluation. “A timely, transparent and internationally aligned regulatory system enables companies to generate evidence, scale new technologies and deliver benefits to patients and the NHS sooner,” he said.
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By GlobalDataUK seeks global competitiveness
While the UK is an established player in the medtech scene, a report from GlobalData reveals that the country lags behind several others in the number of pipeline products – including the US, Europe and China, to name a few.
The reimbursement landscape within the UK can also prove challenging for companies looking to commercialise their products, as the National Health Service (NHS) faces notable budget constraints.
Dr Rob Learney, founder and CEO of UK-based Accunea, noted that UK investor appetite for medtech – especially devices – is not keeping pace with innovation in this field in a previous conversation with Medical Device Network. This led the company to scale abroad, as the US, the Middle East, China and parts of Europe “step in where UK investment falters”.
According to GlobalData, the UK’s medical devices industry is set to reach a value of $35.8bn in 2035.
