Key Takeaways

• Clinical investigations of medical devices in Great Britain increased by 17%, reaching a record 98 approvals in 2025.
• Investment in neurotechnology and AI-driven devices, particularly for conditions like dementia and epilepsy, is driving this surge.
• The MHRA is implementing measures to support innovation and streamline processes for smaller companies in the health tech sector.

Record-Breaking Clinical Investigations in Medical Devices

Clinical investigations for medical devices in Great Britain reached an unprecedented level in 2025, with the Medicines and Healthcare products Regulatory Agency (MHRA) reporting a 17% increase in approved studies—from 84 in 2024 to 98 this year. This surge is attributed to escalating investments in neurotechnology and artificial intelligence (AI)-powered medical devices, particularly in sectors focused on brain and neurological health.

Lawrence Tallon, chief executive of the MHRA, highlighted that 2025 has been a remarkable year for medical device innovation in the UK. He noted the influx of groundbreaking technologies, especially those aimed at addressing urgent patient needs in brain health. The MHRA’s current emphasis is on promoting cutting-edge ideas while eliminating unnecessary regulatory barriers, all while prioritizing patient safety.

The growth in neurotechnology research is particularly notable, with the number of applications doubling since 2024, now representing about 25% of all submissions. A recent breakthrough includes a pioneering study conducted by Great Ormond Street Hospital, University College London, and the University of Oxford, which aims to test a rechargeable brain stimulation device for children suffering from severe, treatment-resistant epilepsy.

The rise in clinical investigations also extends to AI-driven devices, which are being developed to enhance the early detection of diseases through medical imaging and to aid healthcare professionals in personalizing treatment plans. Innovative solutions like apps to aid chronic obstructive pulmonary disease (COPD) patients in managing their conditions in real time are among the new studies complementing this trend.

Mark Grumbridge, head of clinical investigations at the MHRA, expressed that these advancements reflect the dedicated efforts of their clinical investigations team and safety assessors, who have been working diligently to provide a swift yet safe service. The agency has expanded specialist consultations for advanced technologies, including neurotech and surgical robotics, to enhance support for innovative health solutions.

To further bolster innovation, the MHRA is introducing various measures aimed at assisting smaller health tech companies. Initiatives include a fee waiver pilot for early access to promising devices and enhanced guidance for high-impact technologies. Furthermore, the MHRA has collaborated with a UK-wide initiative led by Newcastle University to revise national guidelines governing neurotechnology, facilitating easier study launches related to brain-interactive devices.

Steve Lee, director of diagnostics and digital regulation at the Association of British HealthTech Industries, commented on the significance of the UK’s ability to attract clinical investigations, viewing it as an essential indicator of the nation’s competitiveness in health tech innovation and investment. Lee stressed that a transparent and internationally aligned regulatory framework allows for quicker evidence generation and technology scaling, ultimately benefiting patients and the National Health Service (NHS).

In a related development, the MHRA recently initiated a consultation regarding the indefinite recognition of CE-marked medical devices in Great Britain, seeking to streamline regulatory processes and further enhance the landscape for medical innovation.

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