New EU guidance on Periodic Safety Update Reports
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance on Periodic Safety Update Reports (PSURs) to assist manufacturers when preparing these documents.
The aim of a PSUR is to summarise the results and conclusions of data gathered as part of post-market surveillance activities (i.e. after the device has been placed on the market). It is a legal requirement for all medical devices in Class IIa and above, and must include the following information:
- The main findings of the Post Market Clinical Follow-up (PMCF)
- A re-assessed risk-benefit analysis
- Data on sales, as well as an estimate of the size and other characteristics of the population using the device.
When preparing a summary of the above information, the MDCG guidance states that manufacturers should consider reports of serious and non-serious incidents relating to the device, feedback and complaints from stakeholders, as well as public information concerning similar medical devices.
In addition, the guidance provides clarity on how to prepare PSURs, noting that the period for collecting data starts from the date of device certification and that reports should generally be drawn up per device model. Manufacturers must continue to prepare PSURs throughout their device’s lifetime. This means that updates must still be provided, even where the manufacture of new devices has stopped, so long as the last device produced is still within its intended period of use.
The frequency for updating PSURs and the method for making them available to relevant notified bodies varies depending on device class. The table below provides a summary of these requirements.
| Class III | Class IIb (implantable) |
Class IIb (non-implantable) |
Class IIa (implantable) | Class IIa (non-implantable) | Class I | |
| PSUR required | Yes | Yes | Yes | Yes | Yes | No |
| Update frequency | Annually | Annually | Annually | Every 2 years | Every 2 years | Not applicable |
| EUDAMED upload | Yes | Yes | No | Yes | No | Not applicable |
To determine the PSUR requirements for your device, it is therefore crucial that you first know your classification under the medical device regulations. Our Regtik platform can help you figure this out - providing a guided assessment that takes your device through the regulatory maze, followed by a fully reasoned report that outlines key information (including device classification and pathways to market). If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.
