Great Britain’s Updated Post-Market Surveillance Requirements Now in Force: What Manufacturers Need to Know

On 16 June 2025, new post-market surveillance (PMS) requirements came into force in Great Britain[1] under The Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 (SI 2024 No. 1368). These changes apply to manufacturers placing medical devices and in vitro diagnostic (IVD) devices on the market in England, Wales and Scotland.

The revised regulations are designed to ensure more proactive monitoring of devices once they are in use. When applied appropriately, these PMS obligations are expected to contribute not only to maintaining the safety and performance of current devices, but also to driving improvements and innovation over time.

A clearer framework for manufacturers

The updated PMS requirements bring Great Britain closer in alignment with global trends. The regulation introduces a structured and proportionate approach to gathering, analysing, and responding to data on device performance in the post-market phase.

Manufacturers are required to implement a PMS system for each device they place on the market or put into service in Great Britain that is proportionate to the risk class and type of device. The system should enable the manufacturer to detect any need for corrective or preventive action (CAPA) and to provide evidence of continued safety and performance of the device and any impact on the post-market surveillance of other devices.

PMS Plans and Reports

Under the new requirements, manufacturers must maintain a PMS plan that outlines how data will be collected and evaluated throughout the device’s PMS period. This plan is expected to be an integral part of the device’s technical documentation.

For medical devices of Class IIa, IIb, III and Active Implantable  and in vitro diagnostic devices covered in IVDD 98/79/EC Annex II List A and B or certified under EU IVDR and Class C or D, a Periodic Safey Update Report (PSUR) is required. All other devices require a PMS report. These reports should summarise findings from post-market activities and may be used to inform updates to clinical evaluation and risk management documentation. They are also expected to support early detection of emerging risks. Guidance on the content and format for the PSUR has been published by MHRA.

Integration with vigilance and corrective actions

The PMS system should be integrated with the manufacturer’s processes for incident reporting and CAPA, including field safety corrective actions. This creates a more cohesive approach to identifying and responding to adverse events and performance issues.

Looking ahead

The introduction of SI 2024 No. 1368 reflects an evolving regulatory landscape in Great Britain. These changes aim to enhance transparency, ensure timely response to safety signals, and foster an evidence-based approach to device monitoring. It is common practice in this industry to view PMS not only as a compliance obligation, but also as a mechanism for continuous product improvement.

Manufacturers placing devices on the Great Britain market are expected to review and, where necessary, update their PMS systems to align with these new requirements. Engaging with updated guidance and keeping abreast of evolving expectations will be important as regulators continue to refine the Great Britain’s medical device framework.