In June 2025, new government measures came into effect to clarify and strengthen post-market surveillance (PMS) requirements for medical devices in Great Britain. These changes aim to improve the identification and management of risks, enabling the Medicines and Healthcare Products Regulatory Agency (MHRA) to better prevent harm and respond to safety concerns.
Building on this, on 1 August 2025, the MHRA published updated guidance on Adverse Event (AE) reporting in digital mental health technologies (DMHTs).
Eamonn McGowran, Associate Director, Regulatory Affairs at Boyds explains the updated regulations.
What are the new regulations?
The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amend the UK Medical Devices Regulations 2002. They introduce new post-market surveillance requirements for medical devices, including in vitro diagnostic devices and active implantable medical devices in Great Britain.
These regulations apply to Great Britain (England, Wales and Scotland). Medical devices placed on the market or in service in Northern Ireland must follow rules set out by the EU instead.
The enhanced regulatory framework will allow the MHRA to identify trends, patterns, or signals that may indicate new risks or emerging safety issues more efficiently.
Adverse Event (AE) reporting for Digital Mental Health Technologies
AE reporting is a critical aspect of patient safety, particularly for digital technologies such as mental health apps, AI-powered diagnostic tools, and virtual reality (VR) therapy solutions.
The remote delivery and complex mechanisms of these technologies pose challenges in identifying and categorising AEs. A study published by JMIR Mental Health found that only 26% of trials reported AEs within their primary results, highlighting the need for clearer reporting guidelines.
The importance of updating regulatory guidance
Updates to regulatory guidance are important for several reasons, including:
- Improved clarity for manufacturers – the MHRA guidance offers specific examples of serious incidents, helping manufacturers understand how DMHTs could fail.
- Enhanced user safety – by identifying potential risks, developers can design safer and more effective technologies.
- Regulatory compliance – clear guidance supports compliance, which is crucial for securing market approval and building user trust.
The MHRA guidance outlines possible scenarios where digital technologies could pose safety risks. These include:
- AI-powered assessments – faulty algorithms may result in misdiagnosis or inappropriate treatment.
- AI chatbots – chatbots may generate harmful, misleading, or biased responses with serious consequences.
- Virtual reality therapy – technical faults could lead to disorientation, anxiety, or other adverse psychological effects.
Software as a Medical Device (SaMD) app compliance
Another recently published report emphasises the growing need for enhanced regulatory compliance in digital health technologies. Analysis of Software as a Medical Device (SaMD) compliance within applications available on the Google Play Store was conducted. The review focused on applications making clinical claims and cross-referenced these claims against regulatory requirements. Out of the 95,731 applications identified as SaMD-likely, 95% lacked verifiable evidence of EU CE marking or US FDA authorisation in public listings.
The analysis highlights a significant public health risk due to the widespread availability of unregulated medical software and underscores the need for more active enforcement by regulatory authorities. The report proposes holding app store operators such as Google and Apple accountable as importers and distributors of medical devices, as per relevant regulations.
Expert guidance on regulatory affairs
This guidance from the MHRA will help developers to improve the safety and effectiveness of DMHTs. If you would like to learn more about this updated regulatory guidance and how it might impact your technology product, get in touch with the regulatory affairs specialists at Boyds team today.