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.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.