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Stay up to date with Post Market Surveillance practices!
A major update to UK Medical Device Regulations 2002 was recently approved in parliament, starting the process for a 2024 update to UK MDR which means medical device manufacturers will need to update their Post-Market Surveillance approach for the UK by June 2025. All medical devices sold in the UK are impacted by this change and manufacturers will need to ensure their PMS activities and documentation are up to date.
Our Quality and Regulatory team have put together a helpful list of Frequently Asked Questions about the changes which can you find below:
What is Post Market Surveillance?
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.
Why have the Post Market Surveillance requirements changed?
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.
When do the new Post Market Surveillance requirements apply? What do I need to do now?
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.
What are the new required Post Market Surveillance documents?
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.
What is the difference between a PMSR and a PSUR?
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.
How similar are the UK and EU PMS regulations after this update?
The updated regulations make the UK and EU more closely aligned, but there are some key differences, such as the need to consider UK-specific sales, patient and usage data on its own, or the requirement to consider feedback from public engagement. Even if you have an EU MDR-compliant PMS system, a gap assessment against the new UK MDR is still necessary.
How have the incident reporting timelines changed?
The former 30-day reporting timeline for identified issues which could represent an anticipated serious deterioration in health (the least serious reportable event type) will now be 15 days. This should be reflected in your vigilance procedures as 15 days is now the longest possible timeline for any sort of reportable incident in the UK.
Are there any standards to explain Post Market Surveillance?
While the MHRA guidance documents on Post-Market Surveillance are very thorough, they do also recommend PD CEN ISO/TR 20416:2020 ‘Medical Devices. Post-market surveillance for manufacturers’ for further guidance on Post-Market Surveillance Processes.
What about Post Market Surveillance for discontinued devices?
If your product is no longer available on the UK market but was previously, you should continue to follow the previous requirements for Post-Market Surveillance – these requirements only apply to products that continue to be placed onto the UK market from 16 June 2025. However, as soon as you place one device on the market after 16 June 2025, the new requirements apply to all devices of that design.
What about Post Market Surveillance for Northern Ireland?
Under the Windsor agreement, despite Northern Ireland being part of the UK, Medical Devices placed onto the Northern Ireland market must follow EU Medical Device requirements, not UK requirements. These amendments don’t impact your product if it is only placed in the Northern Ireland market.
Need Help with updating your Post Market Surveillance documentation?
Get in touch for a free consultation and review of your documentation led by our Quality and Regulatory team.
