How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.
UK MHRA · March 30, 2026
Guidance: Medical devices that need a clinical investigation
Explains how to determine whether a medical device requires a clinical investigation or qualifies for exemption under regulations.
Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.