New regulations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) around post-market surveillance (PMS) requirements for medical devices have come into effect.
An amendment to the MHRA’s UK Medical Devices Regulations 2002, the revised regulation stipulates that all medical device manufacturers with UKCA- and CE-marked products placed on the UK market after 16 June 2025 must ‘proactively track’ their safety and performance.
Medical devices and products in the scope of the new requirements include in vitro diagnostic (IVD) devices such as glucose monitors, active implantable medical devices including pacemakers and hearing implants, and various technologies used across hospitals, clinics, and home care settings.
The regulation, which the agency said will help identify potential safety issues earlier and “strengthen protection for patients and the public through faster responses to incidents and emerging risks”, tightens up a range of safety monitoring protocols.
Medical device manufacturers are now required to collect and assess real-world safety and performance data, report serious incidents to the MHRA within 15 days – opposed to 30 days before the regulatory amendment – submit essential communications on patient safety to the MHRA for review before sharing with users, and provide PMS or Periodic Safety Update Reports (PSUR) to the MHRA within three days of request.
MHRA CEO 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.”
The MHRA added that the new PMS regulation lays the groundwork for future reforms, including potential international recognition routes, all of which are designed to support improved access to safe and effective innovations as part of the UK’s “broader commitment” to a regulatory framework that “supports both patient safety and innovation in life sciences”.
Implementation of the MHRA’s new measure became law on 16 December 2024, with the six-month implementation period ending today (16 June). The amended rules were in part informed by recommendations from the Independent Medicines and Medical Devices Safety (IMMDS) Review, which concluded on 31 July 2020.
