The MHRA has published new guidance on device characterisation, regulatory qualification, and classification:
👉 Digital Mental Health Technology – Regulation and Evaluation for Safe & Effective Products
This guidance is applicable to Digital Mental Health Technology (DMHT) products placed on the UK market, covering Great Britain (England, Wales, Scotland) and Northern Ireland. It explains the regulation and evaluation of DMHT to ensure only safe and effective products are made available in the UK.
📌 Some DMHTs qualify as Software as a Medical Device (SaMD) and must comply with relevant medical device regulations. The guidance provides clarity on:
✔️ How to determine if a DMHT is classified as SaMD
✔️ The role of UKCA / CE certification in demonstrating compliance
A crucial step towards patient safety and regulatory clarity in digital mental health!