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

Documents

Submitting a clinical investigation proposal for MHRA assessment

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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.

Published 31 March 2026