Digital mental health technology: qualification and classification
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Latest change: - Added numbering for titles. - Update to section ‘2. Development of this guidance’ to include details of stakeholder engagement. - Update to section ‘6. Determining qualification as SaMD’ to include info on when DMHT does not qualify as SaMD. - Update to section ‘6.2 Does the DMHT have sufficient functionality?’ to include background of concepts in EU and UK guidance. - Wording for function 10. - Update to ‘7. Accessories, multi-modular and inter-connected DMHTs’ for clarification. - Update to ‘8.2. EU MDR classification rules for DMHTs’ due to published EU MDCG 2019-11 Rev 1 Guidance on qualification and classification of software in regulation (EU) 2017/745 - MDR and IVDR (2019).
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