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UK Medical Device Testing Hits Record High

Tom Quinn

,

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

The UK saw a sharp rise in medical device trials last year, with the Medicines and Healthcare products Regulatory Agency (MHRA) reporting 17% more clinical investigations approved in 2025 as cutting-edge medtechs race to market.

The regulator, which oversees the safety and performance of all UK medicines and medical devices, said that the uptick in applications reflects heightened interest in high-impact health technologies, particularly within neurotechnology and AI-powered medical devices.

The MHRA said that it has seen huge investment into trials for conditions like dementia, Parkinson’s disease and epilepsy, with studies in this area doubling since 2024 to make up around a quarter of all UK applications.   

Recent approvals in this area include a study exploring how deep brain stimulation can help treat addiction, and first-in-human paediatric research led by Great Ormond Street Hospital to test a rechargeable brain device designed to reduce seizures in children with severe, treatment-resistant epilepsy.

The watchdog said it has also seen a surge in applications for AI‑enabled tools, spanning everything from early‑detection scanners to real‑time treatment systems and new technologies for preserving and restoring eyesight.

MHRA said that testing these innovative health solutions in the UK has meant earlier access to potentially life-changing tech for patients, while offering the NHS better tools to diagnose disease, manage long-term illness and deliver more precise treatment.

According to the regulator, healthtech companies are increasingly choosing the UK as a proving ground thanks to the “speed, certainty and expertise” offered through its clearance pathway.

The MHRA claims it has met 100% of its statutory deadlines for clinical investigation applications since September 2023, with average approval times for clinical investigations last year sitting at 51 days, nine days faster than its target.

In contrast, the US Food and Drug Administration has reportedly seen about 70% to 80% of applications exceeding its 90-day review target.

To build on this momentum, the MHRA said it is rolling out a package of measures designed to back the most innovative health technologies and further cut barriers for smaller companies.

For example, from January 2026, the MHRA waived fees for micro and small UK firms in a pilot scheme to help unlock high-potential ideas that might otherwise stall due to early costs. 


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Meanwhile, the regulator has also been involved in a UK-wide partnership to update guidance on neurotechnology research to clear the way for clinicians, researchers and companies to launch studies involving devices interacting with the brain and nervous system.

“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,” said Lawrence Tallon, MHRA chief executive.

“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.”

Tom Quinn

Staff Writer, DIGIT

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