Regulations from the Medicines and Healthcare products Regulatory Agency (MHRA) have entered into force, requiring manufacturers to “actively monitor” the safety and performance of medical devices once on the market.
The post-market surveillance regulations have been designed to help identify potential safety issues earlier and to enable faster responses to incidents and emerging risks, the agency shared.
The Medical Devices (Post-Market Surveillance Requirements) Regulations 2024 entered into law on 16 December 2024, taking effect from 16 June following a six-month implementation period. The regulations apply to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025, including in vitro diagnostic devices, and active implantable medical devices such as pacemakers and hearing implants.
Key requirements for manufacturers include the collection of real-world data on device performance in everyday use, expanded scope for incident reporting, shorter timelines for reporting serious incidents, new data analysis reporting to support earlier detection of trends, and stronger duties toward assessing, managing, and notifying users of risks.
The agency has published implementation guidance setting out how the requirements apply across different device types and offering information for manufacturers. It also shares: “The new implementation guide for Manufacturers Online Reporting Environment clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025.”
Lawrence Tallon, MHRA chief executive, points to the need for regulation to keep pace with innovation in health technologies, referring to the new regulations as “a critical step in ensuring safety standards evolve alongside this progress”. He added: “By strengthening oversight of devices once they’re in use and setting clearer expectations for manufacturers, these new regulations provide a robust framework for identifying risks earlier and responding to protect patients.”
Key developments in MHRA regulation across health and care
Late last year, the Medical and Healthcare products Regulatory Agency selected five new technologies as part of the AI Airlock scheme, “to better understand how we can regulate artificial intelligence powered medical devices”. This includes medical devices for cancer, chronic respiratory disease and radiology diagnostic services.
The MHRA also published guidance in February focusing on developing safeguards, regulation and evaluation for UK digital mental health technologies including mental health apps, AI-powered assessments, and virtual reality therapy.
Earlier this month, the agency announced the launch of a digital hub in Leeds with a view to driving partnerships and innovation across the region. Set to be located in Wellington Place in Leeds city centre, the hub will initially be staffed by 30 permanent and highly-skilled roles that will sit within the Digital and Technology Group, focused on digital delivery, software development and data science.
