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: 6 August 2026
  Show all updates

  1. 6 August 2026

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

  2. 23 July 2026

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

  3. 31 March 2026

     First published.

Documents

Submitting a clinical investigation proposal for MHRA assessment

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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.