Description: Post-market Surveillance shall be implemented in order to update the Technical Documentation, once the data are gathered, recorded and analyzed. According to Medical Device Regulation, some of those data will lead to a Period Safety Update Report (PSUR), where the Regulation defines the content of it at the article 86, and depending on the classification of the device, the frequency of the update, the upload in the Eudamed database or the availability to the Notified Body and the Competent Authorities.
Through this requirement, the Medical Device Regulation makes publicly available some information for class III and class IIb implantable devices, which was not the case before: a most challenging situation for manufacturers.
The goal of the session is to explain the content of a Periodic Safety Update Report, where the information comes from, how it is handled, and how the PSUR output is used. The relationship between amongst others risk management, Post Market Clinical follow-up (PMCF), vigilance, trend reporting and the Clinical Evaluation Report (CER) will be discussed. The practical implementation of the PSUR process, including timelines to gather data to meet the required frequency of preparation of the PSUR will be described.
Alex Laan has taken over as speaker from Christine Quinton.
Learning Objectives:
• To know about the output of Post-Surveillance process
• To know about the content of the PSUR
• To know the frequency of update of the PSUR depending on the classification of the device
