What is a PSUR under the Medical Device Regulation (MDR) and Why Is It Important?
A PSUR is a document prepared by manufacturers of certain classes of medical devices that summarizes the results and conclusions drawn from the analysis of PMS data collected as part of the manufacturer's PMS plan. PMS is a crucial aspect of maintaining the safety and efficacy of medical devices once they are on the market and ensuring that real world data matches the expectations of the manufacturer based on bench testing and clinical studies. The PSUR includes:
- The conclusions of the benefit-risk analysis.
- Main findings from Post-Market Clinical Follow-up (PMCF).
- Data regarding the sales, usage, and population characteristics of the device.
How Often Should You Update Your PSUR? PSUR Frequency Requirements by Device Class
- Class IIb and Class III Devices: Manufacturers are required to update their PSURs at least annually and promptly act upon any new data or trends. This means that within a year of the EU MDR certification date or the date of the 2023/607 transition letter, manufacturers must submit the PSUR to the Notified Body, even where the full MDR assessment has not been performed.
- Class IIa Devices: Manufacturers update the PSURs as necessary and at least every two years.
- Custom-Made Devices: For these unique devices, the PSUR forms part of the documentation required under Annex XIII of the MDR.
Note: PMS requirements of the EU MDR also apply to legacy devices under the MDD/AIMDD. For these devices, classification is under the Directive and the manufacturer’s issuance of the PSUR remains mandatory after the transition period until the end of the device lifetime defined in the technical documentation
PSUR Submission and Review Process under the Medical Device Regulation (MDR)
For Class III and implantable devices, manufacturers must submit PSURs electronically to the Notified Body involved in the conformity assessment. The Notified Body reviews the report and adds its evaluation. This information will be uploaded to the EUDAMED (European Database on Medical Devices), making it accessible to all competent authorities. For other classes of devices, manufacturers must make PSURs available to the Notified Body and, upon request, to competent authorities. The PSUR may be requested as part of routine surveillance; but is also likely to be requested by the EU competent authority or notified body where there are safety signals associated with a particular device or market information that suggests a new risk related to the type of device or its use.
Key Components of a PSUR under the Medical Device Regulation (MDR)
The PSUR must include:
- Benefit-Risk Determination: An ongoing and justified assessment of whether the benefits of the device continue to outweigh the risks.
- PMCF Findings: Results from the ongoing collection of real-world clinical data according to the PMCF plan.
- Sales and Usage Data: Information about the volume of sales, characteristics of the user population, and frequency of use.
Compliance and the Role of the PMS Plan
Manufacturers must demonstrate compliance with Article 83 of the MDR through a detailed PMS plan. This plan outlines how the manufacturer will collect and use information from various sources, including:
- Serious incident reports.
- Non-serious incident data.
- Technical literature.
- Feedback from users.
- Publicly available information about similar devices.
Guidance and Implementation
The Medical Device Coordination Group (MDCG) provided guidance in December 2022 to assist manufacturers in implementing PSUR requirements. This guidance clarifies terminology, including what constitutes a "device certification date" and defines terms such as "legacy devices" and "leading device”. Manufacturers are encouraged to adapt their quality management systems in line with these requirements; there is some flexibility as long as compliance with Article 86 is demonstrated.
Conclusion
The PSUR is an essential tool for maintaining the safety and efficacy of medical devices throughout their lifecycle. By requiring regular updates and thorough analysis of PMS data, the MDR aims to ensure that any risks associated with medical devices are identified and mitigated promptly. Manufacturers must stay vigilant and adhere to the guidelines to ensure their devices remain safe and effective for users.
If you are unsure about your PSUR requirements, please contact your DQS representative and we can explain the timing.
