Guidance

Medical devices that need a clinical investigation

How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.

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

Applies to England, Scotland and Wales

Documents

Clinical investigations flow chart

PNG, 200 KB

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Determining if a clinical investigations is required

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Details

This guidance helps manufacturers to work out if a clinical investigation is necessary according to the UK Medical Device Regulations 2002 (SI 2002, No 618, as amended). It applies to general medical devices and active implantable medical devices only.

The documentation provides an explanation of the flow chart and we recommend viewing the flowchart before reading the explanatory guide.

You should read this guidance alongside our guidance on:

• how to tell if your device is a medical device

• how to notify the MHRA about a clinical investigation for a medical device

Published 30 March 2026