The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Community of Practice for Digital Mental Health Technologies, intended to improve regulatory understanding and practical support for developers in a fast-growing part of UK medtech.
The initiative is meant to help innovators navigate regulatory expectations, improve compliance and move safe, effective digital mental health products into clinical use. The agency said demand has grown for clarity on evidence requirements, post-market responsibilities and the regulatory treatment of software-based and AI-enabled mental health tools.
Shared learning across the sector
The community will bring together developers, clinicians, researchers, commissioners and regulatory specialists. Its objectives include helping developers interpret requirements and build compliance into product design earlier; identifying common challenges, particularly for small and medium-sized enterprises; sharing experience from organisations already using regulatory pathways; and strengthening dialogue between industry and regulators on safety, performance and evidence expectations.
The MHRA has also opened a survey to help set the community’s initial priorities. It asks digital mental health technology developers and other stakeholders about current regulatory challenges, where clearer guidance is needed and how compliance support could be improved. The agency is encouraging broad participation so that the community reflects real-world needs rather than top-down assumptions.
For developers, the survey offers a direct route to influence future regulatory support and help shape a more predictable and transparent environment for innovation. The MHRA is asking participants to share the survey within their organisations.