MHRA: record UK device trials in 2025 as AI, neurotech rise

If you teach or study health tech, here’s the headline we can learn from together. The MHRA says 2025 set a record for UK medical device testing, with approvals for clinical investigations up 17% on 2024. The update, published on 19 February 2026, highlights especially strong momentum in brain technologies and AI. (gov.uk)

Quick explainer you can use in class: a clinical investigation is the medical‑device equivalent of a clinical trial. Manufacturers run a study with patients to collect evidence on safety and performance. In Great Britain, you must tell the MHRA at least 60 days before you plan to start; once your application is validated, a formal 60‑day assessment window begins and you should receive a ‘no objection’ or ‘objection’ letter by day 60. That decision is separate from NHS ethics and hospital site set‑up. (gov.uk)

What this means for patients and the NHS is simple but powerful: earlier access to promising tools, better ways to diagnose disease, and more precise care-while keeping safety checks in place. That is the balance the regulator is trying to strike. (gov.uk)

Timelines matter for students planning projects and for start‑ups mapping costs. The MHRA reports it has met 100% of statutory deadlines for clinical investigation applications since September 2023. In 2025, the average time to approval was 51 days-nine days quicker than the 60‑day target-which gives teams clearer planning assumptions. (gov.uk)

Brain technologies are a big driver of growth. According to the MHRA, neurotechnology studies doubled since 2024 and now make up about a quarter of UK applications. Examples include a feasibility study testing whether deep brain stimulation could help treat addiction. In paediatrics, a Great Ormond Street Hospital–UCL–Oxford team is trialling a rechargeable, skull‑mounted stimulator for children with severe, treatment‑resistant epilepsy to cut seizure frequency; GOSH reported its first UK patient in 2024. (gov.uk)

AI‑enabled devices are also surging. Think image‑analysis tools that flag disease earlier, decision‑support that helps clinicians choose treatments, and apps that adjust care plans in real time-for example in chronic obstructive pulmonary disease. Eye‑care studies are rising too, aiming to protect or restore vision. The common aim: faster diagnosis and more personalised care if the evidence is strong. (gov.uk)

If you’re learning how AI or neurotech becomes ‘regulated’, here’s a rule of thumb for discussion: when software or hardware influences diagnosis or treatment for an individual, it is usually treated as a medical device in the UK-so you need robust evidence before wider use. Clinical investigations are the pathway that generates this evidence for regulators and the NHS. (gov.uk)

There is targeted help for smaller teams. From 5 January to 31 March 2026, the MHRA is running a pilot that waives the clinical investigation application fee for up to ten innovative devices from UK‑based micro and small enterprises. Eligible classes include I, IIa and IIb. To qualify, teams must show the device is genuinely new, addresses an unmet UK clinical need, and can scale for patients or providers. If granted, no application fee is payable; if not, standard fees apply. The pilot can close early once ten waivers are issued, and the MHRA will publish next steps afterwards. (gov.uk)

Beyond fees, the regulator says it is expanding scientific advice meetings, offering enhanced support for high‑impact technologies, and creating routes to earlier market access for promising devices while protecting patients. For students and founders alike, early advice can prevent redesigns later. (gov.uk)

Planning tip for your project timeline: the MHRA’s 60‑day clock starts only after your application is validated; if reviewers raise questions, the clock restarts when you provide a satisfactory response. A decision letter should arrive by day 60. For studies that are both a medicine trial and a device investigation, the ‘IMP+Device’ route aims for aligned outcomes around day 60; this approach took effect on 5 January 2026 and will be reviewed after April 2026. (gov.uk)

Watch this space in brain tech. The MHRA has joined a UK‑wide partnership led by Newcastle University-funded by ARIA-to develop clear national guidance on neurotechnology research, from implanted brain‑computer interfaces to wearables. The goal is to make it quicker and clearer for clinicians, researchers and companies to launch responsible studies. (ncl.ac.uk)

Final takeaway for the classroom: momentum is real, but ‘approval to investigate’ is not ‘approval to market’. Keep patient safety and meaningful evidence at the centre, use advice meetings early, and track the fee‑waiver pilot’s post‑March update if you’re a small UK team preparing your first study. (gov.uk)