UK sees 17% increase in approved clinical investigations for devices in 2025

KEY INFORMATION:

• Approved clinical investigations for medical devices in the UK rose by 17 per cent in 2025 compared to 2024.
• Neurotechnology studies, focusing on conditions like dementia and epilepsy, have doubled since 2024.
• The MHRA is meeting 100 per cent of statutory deadlines, with an average approval time of 51 days.
• A new fee waiver pilot launched in January 2026 helps micro and small UK firms with early costs.
• Advancements in AI-powered tools and eye technologies are providing the NHS with better diagnostic and treatment options.

UK patients are set to become some of the first in the world to access breakthrough medical treatments as clinical investigations hit record levels.

New data from the Medicines and Healthcare products Regulatory Agency (MHRA) confirms a 17 per cent increase in approved investigations during 2025. This surge is largely driven by a global race to develop cutting-edge technologies in artificial intelligence (AI) and neurotechnology.

Breakthroughs in brain health and AI

The most rapid growth has occurred in neurotechnology. Studies in this field—targeting conditions such as Parkinson’s disease, dementia, and epilepsy—have doubled since 2024. These investigations now account for a quarter of all UK applications.

Notable approvals include feasibility studies for deep brain stimulation to treat addiction and first-in-human research for rechargeable devices designed to reduce seizures in children with treatment-resistant epilepsy. Additionally, AI-powered devices are surging, with new tools scanning medical images to spot diseases earlier and apps helping patients manage chronic conditions in real time.

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.”

Supporting small businesses and innovation

To maintain this momentum, the MHRA has introduced measures to support smaller companies. In January 2026, a fee waiver pilot was launched for micro and small UK firms. This initiative aims to unlock high-potential ideas that might otherwise stall due to high initial regulatory costs.

The regulatory body has also streamlined its internal processes. Since September 2023, the MHRA has met 100 per cent of its statutory deadlines. The average approval time for a clinical investigation in 2025 was just 51 days—nine days faster than the 60-day target.

A collaborative approach to future health

The UK is also updating national guidance on neurotechnology research through a partnership led by Newcastle University. This will make it quicker for clinicians and researchers 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.”

OFFICIAL SOURCE VERIFICATION: This report is based on official data from Council / Local Authority. Document: UK medical device testing hits record high as MHRA backs growth in brain and AI technology Source Link: https://www.gov.uk/government/news/uk-medical-device-testing-hits-record-high-as-mhra-backs-growth-in-brain-and-ai-technology

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