UK MHRA · March 30, 2026

Guidance: Clinical investigations: statistical considerations

MHRA guidance on statistical data requirements for clinical investigations of medical devices.

Medium impact Medical Devices Clinical Trials UK medical-devicesclinical-evaluationpost-market-surveillance

How to make sure that you are providing the statistical data required as part of a clinical investigation of your medical device.

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Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.