UK MHRA · December 15, 2025

Guidance: In Vitro Diagnostic roadmap

MHRA sets out deliverables and timelines to support safe development of in vitro diagnostic medical devices.

High obligation Sector Medical Devices & IVD UK In vitro diagnosticsMedical devicesPost-market surveillance

Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.

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