The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Community of Practice for Digital Mental Health Technologies, a forum intended to deepen regulatory understanding and give developers practical support in one of the fastest-growing areas of UK medtech.
The announcement, published on the MHRA's official blog, describes a coordinated effort to help innovators interpret regulatory expectations, improve compliance and move safe, effective digital mental health products into clinical use. The agency frames the initiative as a response to rising demand for clarity on evidence requirements, post-market responsibilities and the regulatory landscape for software-based and AI-enabled mental health tools.
A forum for shared learning
The community is to bring together developers, clinicians, researchers, commissioners and regulatory specialists so that best practice is understood in common. As the field widens from therapeutic apps to AI-supported assessment tools, the announcement argues, consistent practical guidance has become more urgent.
Stated objectives include:
- helping developers interpret regulatory requirements and build compliance into product design at an earlier stage;
- identifying the challenges innovators commonly face, particularly 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 so that emerging technologies meet expectations on safety, performance and evidence.
Survey to set initial priorities
To shape 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, the areas where clearer guidance is needed and ways to improve compliance support.
The agency is seeking broad participation so that the community reflects real-world needs rather than top-down assumptions; for developers, the survey is described as a direct route to influence future regulatory support. The announcement encourages readers to complete the survey and circulate the link within their organisations, arguing that a strong response will help the community deliver meaningful support and accelerate safe innovation for patients.