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.
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.