UK MHRA · July 29, 2026

Guidance: Ambient voice technology-enabled products

Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.

High obligation Sector Medical Devices & IVD Digital Health & AI UK Software as a medical deviceDevice classificationMedical devices

Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.

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