Medical devices that need a clinical investigation

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