UK medical device testing hits record high as MHRA backs growth in brain and AI technology

UK patients could be among the first in the world to benefit from breakthrough medical devices, as clinical investigations reach their highest level on record in 2025.

New figures from the Medicines and Healthcare products Regulatory Agency (MHRA) show a 17 per cent rise in approved clinical investigations compared with last year, as companies increasingly choose Great Britain to test cutting-edge health technologies. At the same time, the MHRA is rolling out new 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.

For patients, this means earlier access to potentially life-changing technologies. For the NHS, it offers better tools to diagnose disease, manage long-term illness and deliver more precise treatment.

The growth reflects a global race to tackle some of the most challenging health conditions. 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. 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.

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, while giving clinicians better information to personalise treatment. Studies in advanced eye technologies have also risen, as companies test new ways to protect vision and restore sight. Together, these advances point to faster diagnosis, more precise treatment and earlier access to breakthroughs for patients.

Companies are looking for speed, certainty and expertise, and this is the offering from the UK. The MHRA has met 100 per cent of its statutory deadlines for clinical investigation applications since September 2023, with average approval times for clinical investigations in 2025 at 51 days, running nine days faster than the 60-day target. Researchers receive hands-on scientific support to help design safer, more robust studies, with specialist advice meetings consistently high.

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

From January 2026, the MHRA has 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.

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.”

In a further boost to one of the fastest-growing fields, the MHRA has announced it is part of a UK-wide partnership led by Newcastle University to update national guidance on neurotechnology research, making it quicker and clearer for clinicians, researchers and companies to launch studies involving devices that interact with the brain and nervous system.

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.

“Maintaining clarity and predictability across the full range of HealthTech products being developed in the UK, including devices, diagnostics and digital products, is essential. The MHRA has a key role to play in maintaining an attractive and trusted environment for research, ensuring that strong research activity translates into sustained growth and improved patient outcomes.”

Together, the record growth in clinical investigations and the MHRA’s new innovation drive aim to cement the UK’s position as a global leader in medical technology – and ensure patients benefit sooner from the next generation of life-changing devices.

Notes to editors 

1. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. 
2. The MHRA is an executive agency of the Department of Health and Social Care. 
3. For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.