Article 80 requires manufacturers of Class C and Class D devices to prepare a Periodic Safety Update Report (PSUR) summarising the PMS-data results and conclusions for each device or category of devices, and updated annually for Class D / every 2 years for Class C, made available through EUDAMED. Article 81 enables the NB to review the PSUR for Class C/D devices and provide an evaluation. For Class A and Class B devices, manufacturers prepare and keep up to date a PMS report (Article 80(1)) - simpler than the PSUR.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.