The UK Medicines and Healthcare products Regulatory Agency (MHRA) has enacted a significant change to medical device regulations in Great Britain with the introduction of the new Post-Market Surveillance (PMS) regulations.
Now in effect, the PMS regulations require manufacturers to actively monitor the safety and performance of their devices once they are available on the market. This regulatory shift is part of a broader initiative by the MHRA to transform the UK’s medical device regulatory framework.
Under the new regulations, manufacturers must track safety and performance data for UKCA- and CE-marked devices sold after 16 June 2025.
The regulations cover various devices, including in vitro diagnostic devices like glucose monitors and prostate-specific antigen tests, active implantable medical devices such as pacemakers and hearing implants. They are also applicable to other technologies used in medical settings.
MHRA chief executive Lawrence Tallon said: “As innovation in health technologies accelerates, regulation must keep pace. Today’s reform is a critical step in ensuring safety standards evolve alongside this progress.
“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.
“This represents an important milestone in our work in building a modern, responsive regulatory system – one that puts patient safety first, while also supporting innovation in life sciences and medical technologies across the UK.”
According to the MHRA, the PMS regulations mandate that manufacturers implement systems to observe device performance, gather comprehensive safety data, promptly report serious incidents, and address issues swiftly.
The MHRA aims for these measures to enhance patient protection by identifying potential risks earlier and responding more quickly to incidents. Trend reporting requirements are introduced to help identify emerging patterns that could threaten patient safety.
Manufacturers are now obliged to collect real-world data on device performance and report serious incidents to the MHRA within 15 days, a reduction from the previous 30-day window. Additionally, they must submit Field Safety Notices for MHRA review before distributing them to users.
For higher-risk devices, UK-approved bodies will monitor the reports, ensuring thorough scrutiny.
The regulations also introduce new data analysis reporting requirements applicable to all devices but particularly beneficial for supervising lower-risk products. Manufacturers must regularly summarise and assess device performance over time.
