Regulatory Updates
View Profile
New MHRA Guidance on Digital Mental Health Technologies (DMHT)
The MHRA has published new guidance on Digital Mental Health Technologies. An overview of how the guidance helps manufacturers determine whether a DMHT qualifies as Software as a Medical Device.
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!
Read the MHRA Guidance
KEY TAKEAWAY
New MHRA Guidance on Digital Mental Health Technologies
The MHRA has published new guidance on Digital Mental Health Technology, covering device characterisation, regulatory qualification, and classification for products placed on the UK market in Great Britain and Northern Ireland. The guidance clarifies how to determine whether a DMHT qualifies as Software as a Medical Device and the role of UKCA and CE certification in demonstrating compliance.
RELATED ARTICLES
