The monitoring of medical device safety is a major concern for regulators, manufacturers, and end users. Periodic Safety Update Reports (PSURs) play a crucial role in this process. Governed by Regulation (EU) 2017/745, commonly known as the Medical Device Regulation (MDR), this process aims to ensure that medical devices authorized on the market remain safe and effective throughout their lifecycle.
This article aims to demystify the PSUR by exploring its nature, requirements, and its impact on medical device safety.
UNDERSTANDING THE PERIODIC SAFETY REPORT FOR MEDICAL DEVICES
The PSUR is essentially a regulatory document that all manufacturers of Class IIa, IIb, and III medical devices must write periodically. This report summarizes the monitoring data collected since the market launch of the device, assessing any potential changes in the product’s risk-benefit profile and including information on all corrective or preventive actions taken.
Writing a PSUR is far from simple. Manufacturers must navigate between strict regulatory requirements and the practical necessities of monitoring their products. Best practice involves integrating the writing of the PSUR into the product development lifecycle, ensuring that necessary data is systematically collected and regularly analyzed.
Here's an infographic illustrating the criteria for requiring or not requiring PSURs for medical devices under European regulations.
Classification and Frequency of Submission
The classification regime and submission frequency of the PSUR depend on the risk class of the medical device:
Class III devices and Class IIb implantables:
These devices require a PSUR every year.
Other Class IIb devices and Class IIa devices:
The PSUR for these categories must be written every two years.
Class I devices:
These devices are generally exempt from PSUR, but require a Post-Market Surveillance Report.
Here's an infographic to illustrate the application of PSUR for MDR-certified devices.
Specific Regulations
The specific requirements for custom-made and legacy devices are particularly important. Custom-made devices must follow particular guidelines, often tailored to their specific use, while legacy devices must comply with both old directives and the new MDR, which can complicate their regulatory management.
Here's an infographic to illustrate the application of PSUR for legacy devices.
THE PROCESS OF WRITING THE PERIODIC SAFETY UPDATE REPORT FOR MEDICAL DEVICES
Writing a PSUR is a detailed process that requires a deep understanding of medical devices and their impact on end-users. It involves the collection, analysis, and synthesis of a broad range of data to ensure the device continues to be safe and effective. Here's an in-depth exploration of the essential steps and contents to include in a PSUR.
1. Summary of Previous Actions
Manufacturer's Actions:
This subsection should document any changes made to the device or its manufacturing processes since the last PSUR. This includes design changes, software updates, process improvements, and actions taken in response to previously identified issues.
Notified Body's Actions:
It should also summarize actions undertaken by the notified body, such as audits, inspections, or documentation reviews that have impacted the device.
2. Justification of Methodological Changes
Each change made to the monitoring or analysis method since the last report must be justified. This justification should explain how the changes contribute to a better assessment of the device’s safety and efficacy, ensuring that the modifications do not introduce bias or limitations in data analysis.
3. Current Evaluation of the Benefit-Risk Profile
Data Collection:
Detail the methods used for data collection, including post-market surveillance, post-commercialization clinical studies, and user feedback.
Data Analysis:
Incidents and Adverse Reactions:
Analysis of reported incidents and adverse reactions, including frequency, severity, and observed trends.
Device Efficacy:
Evaluation of data on device efficacy, including improvements or declines in performance.
Risk Analysis:
Review of identified and emerging risks associated with the device. This includes an assessment of mitigation measures in place and their effectiveness.
Synthesis of Information:
Integration of data to assess whether the device continues to have a favorable benefit-risk profile. This involves comparing benefits and risks in the context of new information available.
4. General Conclusion
This section should provide a comprehensive synthesis that encapsulates the findings of the analyses. It should clearly indicate whether the medical device continues to meet regulatory requirements in terms of safety and efficacy. Recommendations for future actions, such as additional monitoring needs, studies, or device modifications, should also be discussed.
5. Recommendations for Future Actions
Based on the analysis of the current benefit-risk profile, the report should propose recommendations for future actions. This may include suggestions for additional studies, changes to post-market surveillance, or improvements to the device design.
Each PSUR should be designed not only as a regulatory document but also as a tool for continuously improving the quality and safety of medical devices. Rigor in data collection and analysis is essential to support the conclusions of the report and ensure end-user safety.
Here's an infographic setting out the information to be considered when drafting the PSUR for medical devices according to MDR requirements.
CONCLUSION
PSURs are more than a regulatory requirement; they are an essential component of the medical device safety monitoring strategy. By providing a regular overview of the benefit-risk profile of devices, they play a crucial role in protecting public health.
For manufacturers, a thorough understanding of the periodic safety update report process and a proactive approach to its implementation can not only help meet regulatory requirements but also enhance the safety and efficacy of medical devices.
This article is not a document from the European Commission and should not be considered as reflecting the official position of the European Commission.
References and Texts:
[1] European parliament and the council of the european union, “REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices.” Accessed: Feb. 13, 2024. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
[2] “MDCG 2022-21. GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR) December 2022. [Online]. Available: MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022 - European Commission (europa.eu)
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