Article 32 requires the manufacturer to draw up, for implantable devices and Class III devices (other than custom-made + investigational), a Summary of Safety and Clinical Performance (SSCP) accessible through EUDAMED in plain language. The SSCP is part of the technical documentation. Article 33 establishes EUDAMED, the European database on medical devices (operated by the Commission), interconnecting the UDI / registration / NB+certificates / clinical-investigations / vigilance / market surveillance modules.
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.