Published on 19 February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed a 17% year‑on‑year rise in approved clinical investigations in 2025, marking a record high and reinforcing Great Britain’s role as a testbed for new medical devices. (gov.uk)
Performance remains a central message: MHRA reports it has met 100% of statutory deadlines for device clinical investigation applications since September 2023, with average approval times in 2025 of 51 days against a 60‑day target. For sponsors, that translates into greater predictability on study start dates. (gov.uk)
Growth is concentrated in frontier areas. Neurotechnology applications have doubled since 2024 and now account for roughly a quarter of UK submissions, alongside a rise in AI‑enabled devices and advanced ophthalmic studies. Recent approvals include a feasibility study of deep‑brain stimulation for addiction. (gov.uk)
Paediatric innovation is also moving earlier into clinic. Great Ormond Street Hospital, working with University College London and the University of Oxford, is leading first‑in‑human research using a rechargeable skull‑mounted stimulator for severe, treatment‑resistant childhood epilepsy. (gosh.nhs.uk)
To reduce early‑stage cost barriers, a pilot fee‑waiver programme for micro and small UK enterprises runs from 5 January to 31 March 2026, offering up to ten waivers for eligible Class I, IIa or IIb studies. Applicants must hold MHRA micro/small enterprise status and demonstrate device novelty, absence of approved alternatives in the UK, and potential to scale. The pilot closes once ten waivers are granted. (gov.uk)
Early market access is being developed in parallel. MHRA’s Statement of Policy Intent, published on 31 July 2025, outlines a new Early Access service to provide time‑limited, conditional access to promising devices addressing unmet clinical need, drawing on learnings from the Unmet Clinical Need Authorisation tool piloted in the Innovative Devices Access Pathway (IDAP). Initial emphasis is on diagnostics. (gov.uk)
IDAP itself has progressed, with eight technologies selected in the pilot phase for integrated regulatory, HTA and adoption support from partners including MHRA, NICE, NHS England and devolved bodies. Sponsors considering UK routes to adoption should watch how IDAP outputs interface with the forthcoming Early Access service. (gov.uk)
For developers planning studies, MHRA guidance requires notification at least 60 days before starting a clinical investigation in Great Britain, with the statutory 60‑day assessment clock commencing the day after a valid application is accepted. Submissions are via IRAS, and separate arrangements apply for studies involving Northern Ireland. Early scientific advice from MHRA remains available for complex technologies. (gov.uk)
Neurotechnology regulation will receive further clarification through a UK‑wide partnership led by Newcastle University, supported by ARIA and involving the MHRA, to update national guidance on studies involving devices that interface with the brain and nervous system. The aim is faster, clearer routes from first‑in‑human to pivotal and post‑market work. (ncl.ac.uk)
For the NHS and commissioners, the regulatory momentum aligns with parallel work on adoption and funding. NHS England and NICE consulted in 2024 on a pathway to accelerate the commissioning of clinically and cost‑effective MedTech recommended by NICE, signalling a stronger join‑up from evidence generation to system uptake. Sponsors should plan evidence packages that satisfy regulatory, HTA and operational requirements from the outset. (england.nhs.uk)
What this means in practice: 2026 offers a window for SMEs with novel, scalable devices to cut early regulatory fees; all developers can expect stable assessment timelines if documentation is complete; and neurotech and AI sponsors should engage early with MHRA advice and the Newcastle‑led guidance project to de‑risk study design. Taken together, these moves are designed to bring effective devices to UK patients sooner while maintaining robust safety oversight. (gov.uk)