Lawrence Tallon, chief executive of 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).
MHRA figures show a 17% increase in approved clinical investigations in Britain compared to last year, rising from 84 in 2024 to 98 in 2025.
The MHRA said the push into the investigation has been driven by investment in neurotechnology and medical devices powered by artificial intelligence.
Lawrence Tallon, chief executive of the MHRA, said: “This has been a banner year for medical device innovation in the UK.
“We are seeing more and more of the world’s most exciting technologies arrive here first, particularly in areas like brain health, where patients urgently need better options.
“Our goal now is to support the most innovative ideas, remove unnecessary barriers and help companies move faster, keeping patient safety at the center of everything we do.”
Dementia, Parkinson’s disease and epilepsy are driving huge investments in neurotechnology, with studies in this area having doubled since 2024 to account for around a quarter of all UK applications, the MHRA said.
Recent approvals include pediatric 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 refractory epilepsy.
Clinical research is also increasing for AI-powered medical devices, including tools that scan medical images to detect diseases earlier, guide treatment decisions, and personalize 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, both of whom have worked tirelessly to provide a faster and more responsive service, whilst maintaining the highest safety standards.
“We have expanded specialist advisory meetings for complex technologies such as neurotechnology, cardiac devices, surgical robotics and artificial intelligence.”
The MHRA is putting measures in place to support innovation and remove barriers for smaller businesses, including a fee exemption pilot, early market access to promising devices, and expanded support for high-impact technologies.
It has also joined a UK-wide partnership led by Newcastle University to update the national guide on neurotechnology researchmaking it easier for doctors, researchers and companies to launch studies with devices that interact with the brain and nervous system.
Steve Lee, director of digital diagnostics and regulation at the Association of British Health Technology Industries, commented: “The UK’s ability to attract clinical research is a key signal of its competitiveness for health technology investment and innovation.
“A timely, transparent and internationally aligned regulatory system allows companies to generate evidence, scale new technologies and deliver benefits to patients and the NHS sooner.
“It is essential to maintain clarity and predictability across the full range of HealthTech products being developed in the UK, including devices, diagnostics and digital products,” Lee said.
Last week, the MHRA launched a consultation on proposals for the indefinite recognition of CE marked medical devices in Britain..
