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:
Excerpt from the official page. The original is authoritative.