The post-market surveillance plan including the post-market clinical follow-up (PMCF) plan; The PMCF evaluation report. All these documents are part of the technical documentation, within the framework of CE marking procedures for devices, regardless of the device class....
When available, the PSUR and Notified Body evaluation report for Class III and Implantable and Class D devices will be uploaded to the European Database on Medical Devices (EUDAMED). Legacy device PSURs (MDR) MDCG 2021-25 states that manufacturers of legacy devices (those that are continued t...