New regulations introduced this summer strengthen how medical devices are monitored once they reach patients and care settings, marking a major step forward in safety, transparency, and innovation.
From 16 June 2025, updated post-market surveillance (PMS) requirements officially came into force across Great Britain under The Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 (SI 2024 No. 1368). These rules apply to all manufacturers placing medical or in vitro diagnostic (IVD) devices on the market in England, Wales, and Scotland.
The goal is simple but crucial — to make sure that once a medical device is in real-world use, it continues to perform safely, effectively, and as intended.
A clearer framework for manufacturers
The updated PMS rules bring Britain’s medical device framework closer in line with international standards, creating a more structured and proportionate approach to post-market monitoring.
Manufacturers are now required to establish a PMS system for each device they market, tailored to the product’s risk class and intended use. This system must allow companies to identify potential safety issues early and take corrective or preventive actions — known as CAPA — where needed.
In practice, this means continuous monitoring of how devices perform once they are in hospitals, clinics, or community care settings, with findings feeding back into safety data and design improvements.
“These regulations represent a significant move toward proactive patient safety,” said a spokesperson from the Medicines and Healthcare products Regulatory Agency (MHRA). “Post-market monitoring is no longer just about compliance — it’s about learning, improving, and preventing harm.”
PMS plans and safety reports
Each manufacturer must now maintain a Post-Market Surveillance Plan, detailing how performance data will be collected, assessed, and acted upon throughout a device’s lifecycle. This plan forms part of the device’s technical documentation and must be regularly reviewed.
Higher-risk medical devices — including Class IIa, IIb, III, Active Implantable and certain IVD devices — will also require a Periodic Safety Update Report (PSUR). Lower-risk devices must maintain a PMS Report.
These documents are central to ensuring early detection of emerging risks and will inform updates to risk management and clinical evaluation files. The MHRA has issued detailed guidance on PSUR content and format to support manufacturers in meeting these expectations.
Integration with vigilance and corrective action systems
A key feature of the new framework is the closer integration of PMS with existing vigilance and incident reporting systems. Manufacturers must align their PMS processes with mechanisms for reporting adverse events, safety alerts, and field corrective actions, creating a unified system that supports swift response to issues as they arise.
What this means for the care and medical community
For health and care professionals who rely on medical devices daily — from wound dressings and monitors to diagnostic kits and implants — the new PMS rules offer reassurance that ongoing safety monitoring is more robust than ever.
“These steps will help ensure that devices used in patient care continue to meet the highest standards of quality,” said Dr. Lorna Matthews, a medical technology policy consultant. “It’s about building trust — for clinicians, carers, and patients alike.”
The new PMS requirements reflect a positive shift in Britain’s health technology landscape — from reactive oversight to continuous learning. For manufacturers, it’s a call to view post-market monitoring not as red tape, but as a tool for innovation and patient safety.
Ultimately, safer devices mean safer care — and that’s a change the entire sector can welcome.
