The UK Medical Device Regulations (UK MDR) are undergoing a significant update, with major changes coming into effect in June 2025. Recently laid before Parliament, this update will introduce new Post Market Surveillance (PMS) requirements for medical devices sold in the UK, aligning closely with European legislation but with important differences.
If you need help navigating these changes and ensuring compliance, get in touch with our expert team for tailored guidance and support.
Post Market Surveillance is a series of processes and associated documents that medical device manufacturers must implement and maintain to ensure patient safety and monitor the device’s effectiveness after release. This is a key component of medical device risk management and is achieved by gathering post-market data, analysing it and making improvements to the device.
The new regulations apply to all medical devices, but the specific requirements vary depending on the device’s classification. The updates were approved by Parliament at the end of 2024 and will come into force on the 16th of June 2025 which gives you a limited time frame to review and adjust your processes.
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Post Market Surveillance or PMS is a series of processes (and associated documents) that medical device manufacturers must implement and maintain in order to ensure patient safety and monitor device effectiveness after release.
Post-Market Surveillance was vaguely defined in the previous regulations and was not delivering the data and oversight of medical devices used in real practice expected by the regulator. These new requirements more clearly define requirements and are intended to ensure better monitoring of product safety after release.
The new requirements come into force from June 2025, so you should be updating your procedures, documents and templates to ensure you have met the new requirements
You may be required to submit a PSUR as soon as June 2026, if your device is high risk and your ISO 13485 auditor will be looking at compliance with new requirements at your next audit.
In addition to new requirements for the PMS plan that was needed before this change, you may now also need to create a Periodic Safety Update Report (PSUR) or a Post Market Surveillance Report (PMSR) depending on the risk classification of your product
A PMSR is for lower-risk (Class I MD/Class A or B IVD) devices and contains a summary of analysis of any post-market surveillance data and corrective or preventive actions from the reporting period. A PSUR is a longer and more structured document; it must contain additional information including risk analyses, a summary of market information, and conclusions from any post-market clinical follow-ups.
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