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 (Article 10(9), aligned with ISO 13485); (3) carry out clinical evaluation (Article 61) + post-market clinical follow-up (PMCF); (4) prepare and update the technical documentation (Annex II + Annex III); (5) carry out conformity assessment (Article 52); (6) place the CE marking + draw up the EU DoC (Article 19 + 20); (7) register manufacturer + device (Article 31); (8) post-market surveillance system (Article 83) + vigilance reports (Article 87); (9) ensure traceability (Article 25); (10) provide implant cards (Article 18) where applicable; (11) corrective action obligation Article 10(12); (12) cooperation with MSA Article 10(14); (13) Article 10(16) financial coverage for civil liability via Article 116.
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.