UK MHRA · October 01, 2025

Guidance: Clinical trials that include an in vitro diagnostic device

Guidance on submitting applications for clinical trials that include an in vitro diagnostic device.

High obligation Sector Clinical Trials & Research Medical Devices & IVD UK Clinical trialsIn vitro diagnosticsClinical 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.