The Periodic Safety Update Report or PSUR for devices is a new requirement that stems from Article 86 of the Regulation (UE) 2017/745 (MDR), implemented by regulators in order to strengthen their surveillance. According to Section 1 of Chapter VII of the MDR, each device manufacturer shall plan, establish, document, implement, maintain, and update a Post-Market Surveillance (PMS) system. This process should be part of the quality management system, appropriately to the type of device and proportionately to the risk class.
Article 84 of the MDR stipulates that manufacturers should document this PMS in a Post-Market Surveillance Plan (PMSP) and disclose the results of this surveillance in a specific report.
For class I devices, this report is called “Post-Market Surveillance Report” while for class IIa or higher this report is called “Periodic Safety Update Report” or PSUR. The new PSUR requirements include more data than the PMS report that manufacturers were used to have under the medical devices directive.
The PSUR is meant to summarize the results and conclusions of the analysis of the PMS data that has been gathered, resulting from the activities detailed in the PMSP, in order to demonstrate that the benefit/risk ratio remains favorable after the marketing of the device.
In addition, any rationale and description of any preventive and corrective actions taken for safety reasons should be included.
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