UK post-market surveillance rules for medical devices take effect

New UK post-market surveillance requirements for medical devices entered into force on 16 June 2025. The rules were made into law on 16 December 2024 under a Statutory Instrument (SI), The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

The SI is part of the broader roadmap for new medical device regulations that the UK Medicines and Healthcare products Regulatory Agency (MHRA) released in January 2024. The plan outlines a path to update the UK’s medical device regulatory framework, which currently relies on outdated EU legislation.

While the initial focus is on post-market surveillance, the MHRA is expected to propose an SI on pre-market measures before Parliament this year. In November 2024, the agency launched a consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices.

Key components of the post-market SI

While we await proposed pre-market rules, medical device manufacturers should turn their attention to the post-market surveillance requirements that have already taken effect. The SI amends the UK Medical Devices Regulations (MDR) 2002 to facilitate greater traceability and swifter reactions from the MHRA. It also seeks to reduce the risk of harm while supporting better risk management and containment of safety issues.

There are a few key changes that manufacturers should keep in mind for all medical devices placed on the UK market or put into service after 16 June 2025. Under the SI, manufacturers must:

• Have a process in place for gathering and analysing feedback and complaints and for ensuring their devices continue to meet appropriate standards of safety and performance. 
• Continually gather information on the performance and safety of their device throughout the post-market surveillance (PMS) period, which should be based on the total device lifetime.
• Define their PMS system within a PMS plan, which should be proportionate to the risk posed by the device. The plan must, at a minimum, specify the objectives of the PMS system, processes to gather information, methods of data analysis, and links to preventive and corrective actions as part of a risk management process, among other requirements.
• Produce either a post-market surveillance report (PMSR) or a periodic safety update report (PSUR) for any devices placed on the market or put into service in Great Britain. The type of report depends on the risk classification of the device. Devices in higher risk classes are subject to greater regulatory oversight and must file a PSUR. Lower-risk devices will be required to file a PMSR.

As legal experts with Hill Dickinson note, while the UK’s new post-market surveillance requirements are similar to equivalent rules under EU medical device regulations, they are not exactly the same. It will be important for manufacturers to understand the UK requirements and how they differ from their obligations under EU law. 

Looking ahead

Medical device manufacturers have had six months since the SI became law to comply with the new rules before they took effect. Any companies not in compliance need to move quickly. In addition, all manufacturers should regularly review the requirements against their new processes to ensure they fully understand their obligations. This will be particularly important over the next three years when they must submit PMSR or PSUR for their devices.

In addition, manufacturers should closely monitor MHRA communications for updates on the proposed SI for pre-market measures and any subsequent guidance documents that may help them prepare for the expanded obligations. 

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