Guidance

Clinical investigations: investigators' responsibilities

How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 30 March 2026

Documents

Guidance for clincal investigators

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This guidance helps clinical investigators understand what needs to be included in a submission notifying the MHRA of a manufacturer’s plans to undertake a clinical investigation, including our approval process, conduct, labelling of devices and what documentation you need to provide.

Published 30 March 2026