UK MHRA · July 29, 2026

Guidance: Digital mental health technology: qualification and classification

Guidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.

High obligation Sector Digital Health & AI Medical Devices & IVD UK Software as a medical deviceDigital therapeuticsDevice classification

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.