Elaboration or Revision of PMSR and PSUR Reports

The placing of a medical device on the market is preceded by an evaluation of the residual risks related to quality, safety and performance. However, this evaluation shall continue throughout the entire lifecycle of the device, including the post-market period. Post-market surveillance allows manufacturers to collect and analyze experiences of the actual use of medical devices. Based on the outcome of this analysis, further actions such as incident reporting to competent authorities, field safety corrective actions or safety warnings to users may be required. Post-market surveillance activities are planned in the Post-market Surveillance Plan and the data is compiled in the Post-marketing Monitoring Report (for class I medical devices) or the Periodic Safety Update Report (for class IIa, IIb and III medical devices). Our unit assists in the elaboration of the PMS Plan with the definition of actions and also the elaboration of PMSR or PSUR.