Change of https://www.gov.uk/government/publications/clinical-investigations-compiling-a-submission

Change description : 2026-08-06 08:16:00: Updates to the ‘Submitting a clinical investigation proposal for MHRA assessment’ document to update and clarify requirements [Guidance and regulation]

Showing diff : 2026-07-23 12:45:53.366836484 +00:00..2026-08-06 08:24:32.601728670 +00:00

Guidance

Clinical investigations: compiling a submission

How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.

From:
Medicines and Healthcare products Regulatory Agency
Published:
31 March 2026
Last updated:
236 JulyAugust 2026 — See all updates

Documents

Submitting a clinical investigation proposal for MHRA assessment

HTML

Details

This guidance will help manufacturers to submit the correct information when applying for approval for a clinical investigation. It includes the documentation you must include for all applications and what additional information we need in certain circumstances.

Updates to this page

Published 31 March 2026
Last updated 236 JulyAugust 2026 — Show all updates

  1. Updates to the 'Submitting a clinical investigation proposal for MHRA assessment' document to update and clarify requirements

  2. Clarified points around software standard IEC 62304, device labelling, essential requirements, risk analysis and cover letter

  3. First published.

Sign up for emails or print this page

Update history

2026-08-06 08:16
Updates to the ‘Submitting a clinical investigation proposal for MHRA assessment’ document to update and clarify requirements

2026-07-23 13:43
Clarified points around software standard IEC 62304, device labelling, essential requirements, risk analysis and cover letter

2026-03-31 13:16
First published.