Key Objectives and Content of a Periodic Safety Update Report (PSUR)

What is the Purpose of the PSUR?

The PSUR serves two primary purposes:

a. Identification and Evaluation of Changes in the Benefit-Risk Profile

The main goal of the PSUR is to provide a summary of the results and conclusions drawn from the analysis of post-market surveillance (PMS) data related to a medical device or a group of devices. The PMS is planned, implemented and reviewed by the manufacturer according to the requirements of the MDR, which takes a risk-based approach to define the frequency and depth of PMS. The analysis helps identify any changes in the benefit-risk profile of the device. The output of the analysis is particularly important for new devices where PMS gathers real world data that reflects the use of the device and where new information, or trends, emerges relating to the safety and performance of the device. Manufacturers must proactively collect PMS data and evaluate it to identify any safety or performance concerns. If adverse changes to the benefit-risk profile are detected, the manufacturer should evaluate this information in the context of the device's clinical evaluation and risk management processes. The PSUR ensures transparency by providing this critical information to the Notified Body and competent authorities involved in the device's conformity assessment.

b. Information on Corrective or Preventive Actions (CAPA)

The PSUR also serves as a tool for reporting any Corrective Actions or Preventive Actions (CAPA) related to the device, as required by Article 83(4) of the MDR. CAPAs in the PSUR include actions taken that:

• Are response to safety issues or performance concerns identified through PMS activities
• Directly impact product safety, performance, or quality.

Detailing the CAPAs in the PSUR ensures that any risks associated with the device are promptly addressed and communicated to the relevant authorities.

What is the Essential Content of the PSUR?

The PSUR must be a clear, organized, and standalone document that provides a comprehensive overview of all PMS activities and data collected for the device. Here is a breakdown of what the PSUR should include:

General Aspects

• Overview: The PSUR should offer a summary of all PMS activities, and the data gathered, without duplicating the details of the PMS Plan. The aim is to present a concise summary of the results, conclusions, and any actions taken.
• Clarity and Organization: The report should be easy to navigate, with information presented in a clear and unambiguous manner. An executive summary highlighting key information on benefits, risks, and any changes in the benefit-risk profile is recommended.
• Consistency: Manufacturers should strive for a consistent format in the PSUR, regardless of the device class, to ensure uniformity in the presentation of information.

Specific Aspects

In line with Article 86(1) of the MDR, the PSUR must include:

• Benefit-Risk Conclusions: A summary of the benefit-risk determination based on the analysis of the PMS data.
• Post-Market Clinical Follow-Up (PMCF) Findings: Key findings from ongoing clinical data collection post-market.

Sales and Usage Data: Information on the volume of sales, the size and characteristics of the population using the device, and, where possible, the frequency of device usage.

Conclusion

The PSUR is a vital document that ensures the continuous monitoring and evaluation of medical devices after they have entered the market. By systematically analyzing post-market data and addressing any emerging risks, manufacturers can ensure that their devices remain safe and effective throughout their lifecycle. Properly preparing and updating the PSUR is not only a regulatory obligation but also a key component of responsible device management.

The layout and content of the document is very important. DQS has seen PSURs spanning more than 800 pages of mainly analysis. The Notified Body must review this content, and the review is billable to the manufacturer. Therefore, making the PSUR concise and focused is critical for clear communication and to keep costs to a minimum.

Disclaimer: These blogs are for information only and are not intended to interpret or replace the content of the MDR or supporting guidance, such as MDCG publications. We cannot guarantee accuracy of the content or interpretation and therefore we recommend all readers consult the source documents.