Article 29 requires the manufacturer to draw up, for Class C and Class D devices (other than performance-study devices), a summary of safety and performance (SSP) accessible through EUDAMED. The SSP is written in plain language and made publicly available; it is part of the technical documentation. Article 30 establishes EUDAMED, the European database on medical devices (operated by the Commission), interconnecting the UDI / registration / NB+certificates / clinical-performance studies / vigilance / market surveillance modules.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.