UK MHRA · October 01, 2025

Guidance: Clinical trials that include an in vitro diagnostic device

MHRA guidance on submitting applications for clinical trials involving in vitro diagnostic devices.

Medium impact Medical Devices Clinical Trials UK ivdclinical-trialsclinical-evaluation

Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device

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