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GuidanceMHRA

Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance

Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.

First published: Aug 1, 2025Last updated: Aug 1, 2025Changes: 1

Latest change: First published.

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