Article 10 imposes the central manufacturer obligations: (1) demonstrate compliance with general safety and performance requirements (Annex I); (2) establish + document + implement + maintain a Quality Management System (QMS, Article 10(8)); (3) carry out clinical/performance evaluation (Article 56) + post-market performance follow-up (PMPF); (4) prepare and update the technical documentation (Annex II + Annex III); (5) carry out conformity assessment (Article 48); (6) place the CE marking + draw up the EU declaration of conformity (Article 17 + 18); (7) register manufacturer + device (Article 28); (8) post-market surveillance system (Article 78) + vigilance reports (Article 82); (9) ensure traceability (Article 25); (10) provide implant cards where applicable.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.