Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new legislation to enhance post-market surveillance requirements for medical devices in Great Britain. This initiative, effective from June 16, 2025, aims to improve patient safety and ensure the effectiveness of medical devices, including digital mental health technologies (DMHTs).
Description
The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented new legislation to enhance post-market surveillance requirements for medical devices in Great Britain, effective from June 16, 2025. This includes the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which introduces a new Part 4A focusing on post-market surveillance (PMS) for medical devices, including in vitro diagnostic devices and active implantable medical devices. The regulations mandate notification of incidents and corrective actions after a device is approved for the market.
The MHRA has updated its processes to better identify trends and signals indicating new risks or safety concerns, thereby improving patient protection. The agency is collaborating with industry stakeholders to facilitate the adoption of these new requirements, particularly concerning digital mental health technologies (DMHTs). Adverse event (AE) reporting is crucial for evaluating DMHTs, which encompass mental health apps, AI-powered assessments, and virtual reality therapy. However, challenges exist in identifying and categorizing AEs due to the remote nature and complexity of these interventions.
A study highlighted significant inconsistencies in AE reporting in DMHT trials, emphasizing the need for specific guidelines to enhance reporting practices. The MHRA is developing updated guidance with input from various stakeholders, including experts and individuals with lived experience, to address these issues. This guidance will provide clear examples of serious incidents related to DMHTs, helping manufacturers understand potential risks and implement necessary safety measures.
Recent MHRA guidance clarifies the classification of DMHTs as software as a medical device (SaMD) under UK law, outlining manufacturers’ obligations to report serious incidents. This independent scrutiny by the MHRA is vital for ensuring the safety and performance of regulated devices. The updated guidance includes examples of serious incidents, such as incorrect AI assessments leading to misdiagnosis or technical failures in VR therapy causing adverse psychological effects.
AI-powered therapy chatbots, while providing accessible mental health support, may introduce biases and harmful consequences. Similarly, technical failures in VR therapy can exacerbate mental health symptoms. Reporting AEs to the MHRA is essential for independent oversight and the implementation of corrective actions to safeguard public safety.
Conclusion
The updated regulatory guidance by the MHRA represents a significant advancement in ensuring the safety and effectiveness of DMHTs. By providing clear examples of serious incidents and involving diverse stakeholders in its development, the guidance aids manufacturers and stakeholders in navigating the regulatory landscape. This initiative underscores the importance of robust post-market surveillance in protecting public health and enhancing the reliability of medical devices.
References
https://www.gov.uk/government/publications/report-on-adverse-event-ae-reporting-in-digital-mental-health-technologies-dmhts-and-the-development-of-updates-to-regulatory-guidance/report-on-adverse-event-ae-reporting-in-digital-mental-health-technologies-dmhts-and-the-development-of-updates-to-regulatory-guidance
