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.
