Understanding Periodic Safety Update Reports (PSUR) for Medical Devices

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.

Early dialogue with notified bodies, for example with our Structured Dialogue format, can be particularly valuable when defining the scope and methodology of PMCF activities. By clarifying expectations in advance, manufacturers can ensure that the data collected will meaningfully support the PSUR and facilitate a smoother review process.

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 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.

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.

General Aspects

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.

•        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.

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.
• Undesirable side effects and field safety corrective actions.
• Trend reports.
• Technical literature.
• Relevant databases or registers.
• Feedback from users.
• Complaints from users, distributors, and importers.
• 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.

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.

If you are unsure about your PSUR requirements, please contact your DQS representative and we can explain the timing.

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.