UK MHRA · July 29, 2026

Guidance: Digital mental health technology: qualification and classification

MHRA guidance to help manufacturers define device characteristics and determine regulatory qualification and classification for digital mental health technologies.

High impact Medical Devices Digital Health & AI UK medical-devicessamdclassificationdigital-therapeutics

Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.

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