Guidance
Approving clinical investigations
How the MHRA decides whether to approve a clinical investigation for medical devices.
Documents
Details
We aim to process applications in the shortest time possible, while ensuring that any risk to the patient and user is minimised and the investigation is justified by the potential benefit to the participants in the proposed clinical investigation.
This guidance explains our processes and timetables for clinical investigations in Great Britain and Northern Ireland.
You should read this alongside our guidance on clinical investigations for medical devices.
Updates to this page
Published 31 March 2026