EU Periodic Safety Update Report (PSUR)

A report that summarizes the results and conclusions of the analysis of the post-market surveillance data gathered as a result of the Post-Market Surveillance Plan. The comprehensive report that presents an evaluation of the risk-benefit balance of a product, considering all available information since the product was marketed or since the last report. 

It includes data on the product's safety, including side effects, incidents, any corrective actions taken, and any new indications or modifications in usage based on real-world evidence. The PSUR helps regulatory authorities continuously monitor products' safety and effectiveness. A PSUR is only required for Class IIA, IIB and III devices.