MHRA reports record-breaking growth in UK medical device testing as clinical investigations rise 17 percent in 2025

Patients in the United Kingdom could soon access groundbreaking medical devices faster than ever, as new figures show clinical investigations hitting record levels.

According to the Medicines and Healthcare products Regulatory Agency (MHRA), 2025 saw a 17 per cent increase in approved clinical investigations compared with 2024.

This surge reflects both the UK’s growing appeal for health tech companies and the regulator’s efforts to streamline innovation.

Early Access to Life-Changing Technologies

For patients, this growth means faster access to devices that could improve or even save lives.

From brain stimulation technologies for epilepsy to AI-powered diagnostic tools, companies are increasingly choosing the UK to test cutting-edge treatments.

The NHS stands to benefit too, gaining advanced tools to diagnose disease, manage chronic conditions, and deliver more precise care.

Neurotechnology Leads the Way

One of the fastest-growing areas is neurotechnology. Studies in brain-related devices doubled in 2025, making up around a quarter of all UK clinical investigation applications. Recent projects include:

• A feasibility study exploring deep brain stimulation for addiction disorders.

• First-in-human paediatric research led by Great Ormond Street Hospital, University College London, and University of Oxford testing a rechargeable brain stimulation device to reduce seizures in children with severe epilepsy.

These initiatives could transform how neurological disorders are treated, offering hope where conventional therapies have limited impact.

AI and Digital Health Innovations on the Rise

AI-powered medical devices are also expanding rapidly. New tools are being developed to:

• Scan medical images to detect disease earlier.

• Personalise treatment in real time for chronic conditions like COPD.

• Protect and restore vision through advanced eye technologies.

Together, these innovations point toward faster diagnoses, more precise treatment, and improved patient outcomes.

Faster, More Predictable Regulatory Approvals

The MHRA has positioned itself as a global leader in regulatory efficiency.

Since September 2023, it has met 100 per cent of statutory deadlines for clinical investigations.

In 2025, the average approval time was 51 days — nine days faster than the target — giving companies speed, certainty, and expert guidance.

Developers also benefit from specialist advice meetings for complex technologies like neurotech, cardiac devices, surgical robotics, and AI tools.

Supporting Innovation and Smaller Companies

To encourage more breakthroughs, the MHRA introduced new measures in 2026:

• Fee waivers for micro and small UK firms in a pilot scheme.

• Early market access for promising devices.

• Enhanced support for high-impact technologies.

According to Lawrence Tallon, these initiatives aim to remove unnecessary barriers while keeping patient safety central.

“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,” he said.

Partnerships and Guidance Updates

The MHRA is also partnering with institutions like Newcastle University to update national guidance on neurotechnology research.

This effort aims to make it quicker and clearer for clinicians, researchers, and companies to launch studies involving devices that interact with the brain and nervous system.

Industry Praise for UK’s Approach

Steve Lee of the Association of British HealthTech Industries highlighted the UK’s attractiveness for HealthTech investment, emphasizing that clear, timely, and internationally aligned regulations help companies scale innovations and bring benefits to patients and the NHS sooner.

What’s Next?

Looking forward, the MHRA plans to:

• Continue supporting high-impact technologies like neurotech, AI, and surgical robotics.

• Expand specialist advice and guidance for smaller companies to bring innovations to market faster.

• Monitor and refine pilot schemes like fee waivers to ensure promising projects are not delayed by early-stage costs.

• Strengthen partnerships with universities and clinical institutions to maintain UK leadership in medical research.

The focus remains on maintaining a balance between patient safety, rapid innovation, and creating a globally competitive environment for medical technology.

Summary

The UK’s medical device sector achieved record growth in 2025, with clinical investigations up 17 per cent compared with the previous year.

The MHRA introduced new measures to support innovation, including fee waivers for small firms, early market access, and specialist guidance for complex technologies.

Neurotechnology studies doubled, AI-powered devices are expanding, and collaborations with leading UK universities aim to streamline research approvals.

With faster approvals, clear regulatory frameworks, and ongoing innovation support, the UK is positioning itself as a global leader in HealthTech, giving patients earlier access to potentially life-changing medical devices.