UK medical device testing hits record high driven by brain research


Lawrence Tallon, chief executive at the Medicines and Healthcare products Regulatory Agency (Credit: MHRA)

Clinical investigations of medical devices reached their highest level on record in 2025, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

Figures from the MHRA show a 17% rise in approved clinical investigations in Great Britain compared with last year, rising from 84 in 2024 to 98 in 2025.

The MHRA said that the boost in research has been driven by investment in neurotechnology and AI-powered medical devices.

Lawrence Tallon, chief executive at MHRA, said: “This has been a standout year for medical device innovation in the UK. 

“We’re seeing more of the world’s most exciting technologies coming here first, particularly in areas like brain health, where patients urgently need better options.

“Our focus now is on backing the most innovative ideas, cutting unnecessary barriers, and helping companies move more quickly while keeping patient safety at the heart of everything we do.” 

Dementia, Parkinson’s disease and epilepsy are driving huge investment in neurotechnology, with studies in this area doubling since 2024 to make up around a quarter of all UK applications, the MHRA said.

Recent approvals include paediatric research led by Great Ormond Street Hospital, University College London and the University of Oxford to test a rechargeable brain stimulation device designed to reduce seizure frequency in children with severe, treatment-resistant epilepsy.

Clinical investigations for AI-powered medical devices are also surging, including tools that scan medical images to spot disease earlier, guide treatment decisions and personalise care. 

New studies include digital tools that adjust treatment in real time, such as an app to help people with chronic obstructive pulmonary disease manage their condition. 

Mark Grumbridge, head of clinical investigations at the MHRA, said: “These results reflect the hard work and expertise of our clinical investigations team and our safety assessors; they both worked tirelessly to deliver a faster, more responsive service while maintaining the highest safety standards.

“We’ve expanded specialist advice meetings for complex technologies such as neurotech, cardiac devices, surgical robotics and artificial intelligence.”

The MHRA is rolling out measures to back innovation and remove barriers for smaller companies, including a fee waiver pilot, early market access to promising devices, and enhanced support for high-impact technologies.

It has also joined a UK-wide partnership led by Newcastle University to update national guidance on neurotechnology research, making it easier for clinicians, researchers and companies to launch studies involving devices that interact with the brain and nervous system.

Commenting, Steve Lee, director of diagnostics and digital regulation at the Association of British HealthTech Industries, said: “The UK’s ability to attract clinical investigations is a key signal of its competitiveness for HealthTech investment and innovation. 

“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. 

“Maintaining clarity and predictability across the full range of HealthTech products being developed in the UK, including devices, diagnostics and digital products, is essential,” Lee said.

Last week, the MHRA launched a consultation on proposals for indefinite recognition of CE-marked medical devices in Great Britain.



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