# Clinical investigations: compiling a submission

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/021a62d6-685e-4d2f-8785-14ede1be67d6
Type: Guidance
Published: March 31, 2026

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

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## Content

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.

## Attachments

- [Submitting a clinical investigation proposal for MHRA assessment](/government/publications/clinical-investigations-compiling-a-submission/submitting-a-clinical-investigation-proposal-for-mhra-assessment)