The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Community of Practice for Digital Mental Health Technologies. The agency said the initiative is intended to strengthen regulatory understanding, shared learning and practical support for developers in a fast-growing area of UK medtech.
In an announcement on its official blog, the MHRA described the community as a coordinated effort to help innovators navigate regulatory expectations, improve compliance and bring safe, effective digital mental health solutions into clinical use. It responds to growing demand for clarity on evidence requirements, post-market responsibilities and the regulatory landscape for software-based and AI-enabled mental health tools, the agency said.
A forum for shared learning
The community is to bring together developers, clinicians, researchers, commissioners and regulatory specialists. As digital mental health technologies expand from therapeutic apps to AI-supported assessment tools, the MHRA said consistent, practical guidance has become more urgent.
The stated objectives are to:
- help developers interpret regulatory requirements and embed compliance earlier in product design;
- identify common challenges, particularly for small and medium-sized enterprises entering the mental health space;
- share real-world experience from organisations already working through regulatory pathways; and
- strengthen dialogue between industry and regulators so emerging technologies meet safety, performance and evidence expectations.
Survey to set initial priorities
The MHRA has also opened a survey to shape the community’s initial priorities. It seeks input from digital mental health technology developers and other stakeholders across the medtech ecosystem on 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 what the MHRA described as a more predictable, transparent environment for innovation.
The MHRA asked developers to complete the survey and share it within their organisations, saying a strong response would help the community deliver practical support and accelerate safe, effective innovation for patients.