In the first of a series of new blog posts focused on compliance issues for medical devices, our Market Surveillance team describes how we will support digital mental health technology developers to understand and navigate the regulatory framework.
Background
The use of software and AI technologies within healthcare is growing rapidly, with many of these technologies playing an increasingly important role in clinical practice and as direct-to-consumer health resources accessible outside of traditional healthcare settings. Depending on their intended purpose and functionality, many of these technologies are regulated as medical devices and are subject to regulatory frameworks intended to ensure safety, effectiveness, and quality.
As with many fast-moving and innovative areas, navigating the regulatory landscape for these technologies can sometimes be complex. Developers may be working across emerging product types, and evolving evidence.
The National Commission into the Regulation of AI in Healthcare has undertaken work to consider the current regulations and make recommendations for a new regulatory framework for AI in healthcare. On 10 September 2026, the National AI Commission published their report Recommendations for a future regulatory framework. The Commission’s central conclusion is that the regulation and assurance of AI in healthcare must become more proportionate, lifecycle-based and system-wide.
The Government published its response on 6 October 2026, accepting all 44 of the recommendations and setting out how they will be taken forward. While this work is taken forward, developers must continue to meet the requirements of the existing regulatory framework.
The National Commission recognised that, as software and AI-enabled medical devices evolve throughout their lifecycle, regulatory oversight needs to evolve with them. It recommended that the MHRA develop more responsive approaches to engagement and compliance, helping manufacturers understand and meet their regulatory responsibilities while enabling issues to be identified and addressed earlier. Accepting this recommendation, we have committed to work with stakeholders to test how these approaches can work in practice, building on work the MHRA was already taking forward to support earlier engagement, strengthen regulatory understanding and address non-compliance.
We recognise the particular regulatory challenges within the Digital Mental Health Technologies (DMHT) landscape, where products often operate across the boundaries of wellbeing and regulated medical device functionality. As a result, this can create challenges for developers on topics such as intended purpose, risk classification (particularly for borderline determinations) and clinical evidence expectations. In addition, the continuous refinement and evolution of these products both during development and after initial market placement means that topics such as usability and post-market monitoring remain especially important activities.
As the sector develops over time, there is a valuable opportunity to develop regulatory approaches and stakeholder engagement strategies that are accessible, agile and capable of supporting innovation while maintaining patient safety and public trust.
We recognise that creating more opportunities for shared discussion and practical engagement can clarify understanding across the sector, improve confidence in navigating these frameworks and support safe and effective innovation whilst embedding regulatory compliance into routine practice across the DMHT landscape. We therefore introducing support for earlier engagement with developers and to encourage practical, sector-wide dialogue that helps teams navigate regulation alongside innovation.
Facilitating a Collaborative Forum within the DMHT Space
To support early engagement and facilitate structured dialogue between the MHRA and the DMHT landscape, we are launching a Community of Practice for developers and manufacturers of DMHTs. The initiative is intended to support capability-building across the sector by creating a collaborative forum focused on developing regulatory understanding throughout the product life cycle.
This Community of Practice will not provide product-specific regulatory advice or endorsement of individual technologies or manufacturers. Instead, it aims to encourage open discussion on common regulatory themes and areas of interest relevant to those within the DMHT sector.
The programme will consist of in-person sessions led by the MHRA and facilitated by an independent host. Utilising feedback received from developers, initial sessions are expected to focus on key areas that frequently pose challenges for developers, including:
- pre-market considerations
- product Classification
- post-market surveillance
A central aim of this work is to better understand which topics developers and manufacturers would find most valuable to explore through a Community of Practice, and where further shared discussion could be most helpful. To support this, we are also launching an anonymous survey for DMHT developers and manufacturers to help shape future sessions. Insights gathered from the survey will help identify common trends and knowledge gaps so that we may prioritise topics for future sessions. Findings will be reviewed across the wider sector to ensure anonymity while informing shared priorities for learning and development. We are planning for the inaugural Community of Practice session to take place in 2027.
Help shape the DMHT Community of Practice: Take part in the survey
The deadline for completing the survey is 11:59pm (UK time) on Thursday 19 November 2026. If you are interested in completing the survey, you may do so via the link below. We will collect data anonymously on your views of your understanding of the following topics, on an assessment scale ranging from ‘Strongly Disagree’ to Strongly Agree’:
- Pre-market considerations
- Product classification
- Clinical Evidence and Risk Management
- Vigilance
- Post-Market Surveillance
The survey is open to all DMHT developers and manufacturers. Completion of the survey does not automatically enrol you in the Community of Practice, as survey responses will be collected anonymously. If you would like to receive information about events and opportunities to get involved, you will have the option to opt in separately and provide your contact details.
This initiative forms part of MHRA’s broader approach to compliance, supporting our new Strategy to 2030, in providing earlier engagement and clearer regulatory guidance, helping innovators and manufacturers navigate regulatory requirements and bring safe, effective products to patients more quickly.
If you would like to take part, please complete the survey.
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