Article 78 requires manufacturers to plan, establish, document, implement, maintain and update a post-market surveillance (PMS) system, proportionate to the risk class and appropriate for the type of device. The PMS system actively + systematically gathers, records and analyses data on the quality, performance and safety of the device throughout its entire lifetime; the PMS plan is part of the technical documentation (Annex III). PMS information feeds back into performance evaluation (Article 56), into vigilance (Articles 82-86), and into the SSP (Article 29).
This control maps to 2 controls across 2 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 2 it maps to, and the evidence behind each claim, over MCP and REST.