UK MHRA · March 30, 2026

Guidance: Clinical investigations: biological safety assessments

MHRA guidance on conducting biological safety evaluation required before undertaking clinical investigations for medical devices.

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

How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a 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.