# Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/ec210b65-59cd-4599-b078-5ee7715a1143
Type: Guidance
Published: August 1, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance regarding market surveillance for medical devices in Great Britain. Under the regulatory framework established by 2024 legislation, the agency has strengthened post-market surveillance requirements to ensure higher safety standards. These new measures officially came into effect on June 16, 2025. The core objective of this update is to facilitate superior traceability of device incidents and identify safety trends more efficiently. By mandating these changes, the MHRA is empowered to intervene more rapidly when safety issues arise, improving risk management and minimizing potential harm to the public. While the source text does not identify a specific company or individual inspection dates, it outlines the mandatory actions for all manufacturers operating in the UK market: they must comply with the enhanced monitoring and reporting protocols. This legislative shift represents a major transition in how the supply and marketing of medical devices are overseen, emphasizing proactive containment of safety issues through a more robust and transparent oversight system. Stakeholders are required to align their internal monitoring processes with these new legal obligations to maintain market access and ensure patient safety across the region.

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## Content

One of the roles of the Medicines and Healthcare products Regulatory Agency (MHRA) is to perform market surveillance of medical devices on the UK market and take decisions over the marketing and supply of devices in the UK. In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. These measures came into force on 16 June 2025 and will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm.

## Attachments

- [Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance](/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)