Article 84 sets out the structure of the PMS plan (Annex III content). Article 85 requires Class I devices to have a PMS report (Annex III) updated when necessary and made available to MSA on request. Article 86 requires Class IIa, IIb and III devices to have a Periodic Safety Update Report (PSUR) summarising the PMS-data results and conclusions, with PSUR submitted via EUDAMED: annual for Class III + implantables / every 2 years for Class IIa / Class IIb. PSUR is reviewed by the NB for Class IIa/IIb/III.
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.