The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Community of Practice for Digital Mental Health Technologies, in a post published on the regulator's official blog.
The agency said the forum is intended to strengthen regulatory understanding and provide practical support to developers in one of the fastest-growing areas of UK medtech. The initiative responds to what the MHRA describes as rising demand for clarity on evidence requirements, post-market responsibilities and the regulatory landscape for software-based and AI-enabled mental health tools.
A sector-wide forum for shared learning
The community is to bring together developers, clinicians, researchers, commissioners and regulatory specialists. Its stated objectives are:
- helping developers interpret regulatory requirements and embed compliance earlier in product design;
- identifying common challenges, particularly for small and medium-sized enterprises entering the mental health space;
- sharing real-world experience from organisations already working through regulatory pathways;
- strengthening dialogue between industry and regulators on safety, performance and evidence expectations.
Survey to shape initial priorities
To set the community's first priorities, the MHRA has opened a survey for digital mental health technology developers and other stakeholders across the medtech ecosystem. It explores current regulatory challenges, where clearer guidance is needed and how compliance support could be improved.
The agency said it wants broad participation so that the community reflects real-world needs rather than top-down assumptions, and is encouraging developers to complete the survey and share it within their organisations. A strong response, it said, will help the community deliver practical support.
The announcement did not specify when the community will launch, how membership will work or how its outputs will be published.