Clinical investigations of medical devices in the UK reached a record high in 2025, rising 17 per cent compared with 2024, as the Medicines and Healthcare Products Regulatory Agency (MHRA) reported accelerating activity in neurotechnology and artificial intelligence-enabled systems. The regulator said the UK medical device testing increase reflects growing interest from companies choosing Great Britain as a base to test advanced health technologies, alongside efforts to streamline approvals and support innovation.
The MHRA stated that it has met 100 per cent of its statutory deadlines for clinical investigation applications since September 2023. In 2025, average approval times stood at 51 days, nine days faster than the 60-day target. The agency said it has also expanded specialist advice meetings for complex technologies, including neurotechnology, cardiac devices, surgical robotics and artificial intelligence.
Neurotechnology emerged as one of the fastest-growing segments. Studies in this area have doubled since 2024 and now account for around a quarter of all UK clinical investigation applications. Recent approvals include a feasibility study exploring whether deep brain stimulation can help treat disorders of addiction, and first-in-human paediatric research led by Great Ormond Street Hospital, University College London and the University of Oxford testing a rechargeable brain stimulation device designed to reduce seizure frequency in children with severe, treatment-resistant epilepsy.
Artificial intelligence-driven medical devices are also increasing. New investigations include systems that scan medical images to detect disease earlier, guide treatment decisions and personalise care. Digital tools that adjust treatment in real time are under study, including an app designed to support people with chronic obstructive pulmonary disease while providing clinicians with enhanced data to tailor therapy. Studies in advanced eye technologies have also risen as companies evaluate new approaches to protect vision and restore sight.
From January 2026, the MHRA introduced a pilot scheme waiving fees for micro and small UK firms to reduce early-stage financial barriers to UK medical device testing . The regulator also announced enhanced support for high-impact technologies and early market access pathways for promising devices.
In addition, the MHRA confirmed it is part of a UK-wide partnership led by Newcastle University to update national guidance on neurotechnology research. The initiative aims to make it quicker and clearer to launch studies involving devices that interact with the brain and nervous system.
MHRA Chief Executive Lawrence Tallon 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.”
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. Our door is open for developers to engage with us early so we can help turn promising concepts into real-world clinical investigations.”
Steve Lee, Director of Diagnostics & Digital Regulation at the Association of British HealthTech Industries (ABHI), 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. We welcome the MHRA’s focus on performance and support for smaller companies.
Clinical investigations are a critical stage in bringing new medical devices from development into clinical use, with regulators assessing safety and effectiveness before wider deployment. The 2025 increase underscores sustained momentum in AI-driven diagnostics, digital health platforms and neurotechnology, as companies seek predictable regulatory timelines and early evidence generation pathways in the UK.