Periodic Safety Update Report (PSUR)

Post-Market Surveillance (PMS) is one of the most important requirements for EU MDR (725/2017) compliance. It plays a major role in bettering the safety and efficacy aspects of the medical device in scope with a real time inputs from the market usage. The data points provide substantial inputs to the risk management framework (benefit-risk analysis), Design & Development, Clinical Evaluation Report (CER), triggering Field Safety Corrective Actions (FSCA), Usability and modifications to the Technical Documentation. The PMS requirements are more prescriptive in European Union (EU) when compared to the other major medical device regulatory jurisdictions like US, Canada etc.

The PMS requirements in EU depend on classification of the medical device in scope. Irrespective of the class of the device, all the medical devices shall have a PMS Plan as suggested in Annex III of the EU MDR. The PMS plan shall typically cover systemic and proactive measures and appropriate methods to be implemented to collect necessary PMS data and refer to the QMS procedures in place. PMS plan shall be part of the Technical Documentation.

A Post-Market Surveillance Report (PMSR) may contain the implementation activity of the PMS plan, volume of sales, estimation of user population, overview of data including adverse events, results of analysis including trends, CAPA, FSCA, conclusions from benefit-risk ratio and final assessment.

The PMSR/PSUR requirements for different classes of the medical devices are summarized in the following table.

Class I manufacturers need to update PMS Reports based on the PMS data gathered as per the PMS plan drafted as part of the Technical Documentation summarizing the corrective and preventive actions taken. The PMS report shall be updated when necessary and made available to the competent authority upon request. On the other hand, Periodic Safety Update Report (PSUR) is basically an extension of a PMS Report which contains information specific to higher risk devices i.e., for Class IIa, Class IIb and Class III.

For implantable and Class III devices, the PSUR shall be submitted to Notified Body for review, after thorough review, notified body uploads the same into EUDAMED. The PSUR, evaluation of the Notified Body is available via the EUDAMED to the competent authority. In the case of Class IIa and non- implantable IIb devices, the PSUR will be submitted to the Notified Body.

The PSUR shall list out the benefit-risk assessment, the critical PMCF findings, volume of sales and an approximate estimation of the population using the device, throughout the lifetime of the device. If information in the PSUR renders that the information in the SSCP as incorrect or incomplete, SSCP gets updated with the information in the latest PSUR. Notified bodies periodically review all the documents in the PMS umbrella (i.e. PMS Plan, PMSR/PSUR, PMCF Plan & Evaluation Report, Updated CER and SSCP) for their appropriateness during surveillance activities.