From the 16th June 2025, new legal requirements for monitoring the safety of medical devices take effect, as part of the MHRA’s broader transformation of the UK’s medical device regulatory framework.
The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. The reform applies to all UKCA- and CE-marked devices placed on the GB market. It requires device manufacturers to actively track the safety and performance of their products. This will help identify potential safety issues earlier and strengthen protection for patients and the public through faster responses to incidents and emerging risks.
Following stakeholder feedback, guidance has been updated to improve clarity and provide further support for manufacturers to help understand the changing obligations. This can be found here.
The new PMS regulation lays the groundwork for future reforms, including potential international recognition routes, designed to support improved access to safe and effective innovations.
Manufacturers are now required to collect and assess real-world safety and performance data; report serious incidents to the MHRA within 15 days (previously 30); submit essential communications on patient safety (Field Safety Notices) to the MHRA for review before sharing with users; and provide PMS Reports or Periodic Safety Update Reports (PSUR) within 3 days of request. For higher risk devices, UK approved bodies will monitor these reports ensuring these products receive a higher level of scrutiny.
The introduction of new data analysis reporting requirements will apply to all medical devices but are particularly valuable for improving oversight of lower-risk devices. These rules will require manufacturers to regularly summarise and assess device performance over time.
Responding to the news, BIVDA’s Regulatory Affairs Manager Neil Plumridge said, “BIVDA welcomes the first major update to the UK Medical Device Regulation 2002 (as Amended) that applies to medical devices and in vitro diagnostic medical devices.
“It is important to note that although closely aligned to the EU IVDR, the PMS SI does include some divergence. We are likely to see a similar approach in the next two pieces of legislation.”
