The new post-market surveillance (PMS) requirements for medical devices in Great Britain (GB) came into effect on 16 June 2025. The requirements are laid down in the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 and are an amendment to the UK Medical Devices Regulations 2002. They represent the first phase in the move towards strengthened regulations for medical devices in Wales, Scotland and England.
PMS is a dynamic and continuous process designed to identify any necessary safety improvements to the medical device and to keep re-assessing the relevance of a device from a safety perspective in an evolving medical market. Put simply, PMS requires the manufacturer to continually ask the question: is the device still safe to use? Answering this question necessitates the proactive and reactive collection and analysis of wide-ranging data specific to the device under scrutiny and its risk class.
What do the new PMS requirements mean for manufacturers of medical devices placed on the GB market?
For any manufacturer familiar with the EU MDR or IVDR, many of the requirements will be recognizable. The PMS Regulations describe the obligations for demonstrating continued compliance with the regulations throughout the lifetime of the medical device, including in vitro diagnostic and active implantable medical devices, and regardless of whether the device is CE or UKCA marked.
More explicit requirements and definitions of key terms provide manufacturers with clearer guidance on when and how to report PMS results and conclusions. The regulations also cover reporting requirements regarding vigilance, with the timelines for reporting serious incidents aligned with those in the EU MDR.
Central to the PMS process is a robust PMS plan and the necessity for this plan is also a new requirement in the PMS Regulations. Defining the objectives, the data to be collected and the methods for analysing the data is crucial for an efficient PMS process that yields meaningful results. It’s a team effort that requires input from multiple departments and output from multiple processes. The outcome of the PMS process leads to any necessary product changes to ensure continued safe use of the medical device, as well as related updates to the technical documentation.
Do you have questions on the most efficient and effective way of implementing a compliant PMS procedure for your medical device? Whether your device is on the market in Great Britain or the EU, our team of medical device experts at Starodub can help you by providing customized support and advice on conducting PMS. Please feel free to contact us through our website to find out more on how we can help you.
