The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new Community of Practice for Digital Mental Health Technologies. The initiative is intended to strengthen regulatory understanding, shared learning and practical support for developers in what the agency describes as one of the fastest-growing areas of UK medtech.
In an announcement published on its official blog, the MHRA said the community would help innovators navigate regulatory expectations, improve compliance and accelerate safe, effective digital mental health solutions into clinical use. The move responds to growing demand for clarity on evidence requirements, post-market responsibilities and the evolving regulatory landscape for software-based and AI-enabled mental health tools.
The announcement comes as software-based and AI-enabled mental health tools raise questions for regulators and developers about evidence requirements and post-market responsibilities.
A forum for shared learning
The community is to bring together developers, clinicians, researchers, commissioners and regulatory specialists. Its purpose is to build a shared understanding of best practice as digital mental health technologies expand from therapeutic apps to AI-supported assessment tools.
The agency says the need for consistent, practical guidance has become more urgent as the field expands.
The MHRA lists four main objectives:
- Supporting developers to interpret regulatory requirements and embed compliance earlier in product design.
- Identifying common challenges faced by innovators, particularly small and medium-sized enterprises entering the mental health space.
- Sharing real-world experience from organisations already navigating regulatory pathways.
- Strengthening dialogue between industry and regulators so emerging technologies meet safety, performance and evidence expectations.
For the wider medtech development community, the agency frames the community as an opportunity to engage directly with the regulator on issues that often determine whether promising technologies reach patients.
Survey to set initial priorities
To shape the community’s initial priorities, the MHRA has opened a survey for digital mental health technology developers and stakeholders across the medtech ecosystem. The survey explores current regulatory challenges, areas where clearer guidance is needed and opportunities to improve compliance support.
The agency is encouraging broad participation so that the community reflects real-world needs rather than top-down assumptions. For developers, it presents a direct route to influence future regulatory support and help shape a more predictable, transparent environment for innovation.
The MHRA is asking digital mental health and wider medtech developers to take part and to share the survey within their organisations. A strong response, the agency says, will help ensure the new community delivers practical, meaningful support that accelerates safe, effective innovation for patients.