Clinical trials for medicines: apply for approval in the UK
Page summary:
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Change made:
Updated link to guidance for IMP+device trials.
Time updated:
9:00am, 9 March 2026
Clinical trials that include an in vitro diagnostic device
Page summary:
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Change made:
Updated wording to align with current guidance on clinical trials that include an IVD.
Time updated:
9:00am, 9 March 2026
Clinical trials for medicines: expert advice
Page summary:
Clinical trial applications that need expert advice from a specialist group or committee.
Change made:
Updated figure to clarify that standard RFI timelines apply where the amended application does not require further expert advice.
Time updated:
9:00am, 9 March 2026
Clinical trials for medicines: modifying a clinical trial approval
Page summary:
Guidance on the various types of modifications that can be made to a clinical trial approval.
Change made:
Updated substantial modification notification form.
Time updated:
9:00am, 9 March 2026
Global impact of UK health data resource highlighted in newly published paper
Page summary:
New analysis shows Clinical Practice Research Datalink has supported groundbreaking medical research across 29 countries with close to 3,800 published studies
Change made:
First published.
Time updated:
10:21am, 10 March 2026
Implementation of medical devices future regime
Page summary:
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Change made:
Updated to fix broken link (https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom)
Time updated:
4:34pm, 12 March 2026
Medical devices: get regulatory advice from the MHRA
Page summary:
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Change made:
Updated to add new form ‘Ask for regulatory advice for medical devices’
Time updated:
4:34pm, 12 March 2026
Medical devices given exceptional use authorisations
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Updated the ‘open’ devices exceptional list to add Medlogical Innovations Pty. Ltd, ProFocal System
Time updated:
1:51pm, 13 March 2026
