@ansvar/eu-regulations-mcp 0.1.0 → 0.2.1
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/LICENSE +190 -21
- package/README.md +159 -26
- package/data/seed/aifmd.json +432 -0
- package/data/seed/applicability/ai-act.json +87 -0
- package/data/seed/applicability/aifmd.json +74 -0
- package/data/seed/applicability/cbam.json +74 -0
- package/data/seed/applicability/cer.json +74 -0
- package/data/seed/applicability/cra.json +77 -0
- package/data/seed/applicability/csddd.json +74 -0
- package/data/seed/applicability/csrd.json +74 -0
- package/data/seed/applicability/cyber_solidarity.json +74 -0
- package/data/seed/applicability/cybersecurity-act.json +69 -0
- package/data/seed/applicability/data-act.json +71 -0
- package/data/seed/applicability/dga.json +74 -0
- package/data/seed/applicability/dma.json +77 -0
- package/data/seed/applicability/dsa.json +71 -0
- package/data/seed/applicability/eecc.json +74 -0
- package/data/seed/applicability/ehds.json +74 -0
- package/data/seed/applicability/eidas2.json +86 -0
- package/data/seed/applicability/eprivacy.json +74 -0
- package/data/seed/applicability/eu_taxonomy.json +74 -0
- package/data/seed/applicability/eucc.json +74 -0
- package/data/seed/applicability/eudr.json +74 -0
- package/data/seed/applicability/gpsr.json +74 -0
- package/data/seed/applicability/ivdr.json +74 -0
- package/data/seed/applicability/led.json +74 -0
- package/data/seed/applicability/machinery.json +74 -0
- package/data/seed/applicability/mdr.json +74 -0
- package/data/seed/applicability/mica.json +74 -0
- package/data/seed/applicability/mifid2.json +74 -0
- package/data/seed/applicability/mifir.json +74 -0
- package/data/seed/applicability/pld.json +74 -0
- package/data/seed/applicability/psd2.json +74 -0
- package/data/seed/applicability/red.json +74 -0
- package/data/seed/applicability/sfdr.json +74 -0
- package/data/seed/applicability/un-r155.json +68 -0
- package/data/seed/applicability/un-r156.json +68 -0
- package/data/seed/cbam.json +397 -0
- package/data/seed/cer.json +233 -0
- package/data/seed/csddd.json +205 -0
- package/data/seed/csrd.json +50 -0
- package/data/seed/cyber_solidarity.json +252 -0
- package/data/seed/data-act.json +517 -0
- package/data/seed/dga.json +342 -0
- package/data/seed/dma.json +499 -0
- package/data/seed/dsa.json +686 -0
- package/data/seed/eecc.json +981 -0
- package/data/seed/ehds.json +638 -0
- package/data/seed/eidas2.json +590 -0
- package/data/seed/eprivacy.json +115 -0
- package/data/seed/eu_taxonomy.json +285 -0
- package/data/seed/eucc.json +386 -0
- package/data/seed/eudr.json +401 -0
- package/data/seed/gpsr.json +462 -0
- package/data/seed/ivdr.json +1036 -0
- package/data/seed/led.json +480 -0
- package/data/seed/machinery.json +513 -0
- package/data/seed/mappings/iso27001-ai-act.json +114 -0
- package/data/seed/mappings/iso27001-aifmd.json +50 -0
- package/data/seed/mappings/iso27001-cbam.json +26 -0
- package/data/seed/mappings/iso27001-cer.json +74 -0
- package/data/seed/mappings/iso27001-cra.json +130 -0
- package/data/seed/mappings/iso27001-csddd.json +50 -0
- package/data/seed/mappings/iso27001-csrd.json +26 -0
- package/data/seed/mappings/iso27001-cyber_solidarity.json +82 -0
- package/data/seed/mappings/iso27001-cybersecurity-act.json +90 -0
- package/data/seed/mappings/iso27001-data-act.json +66 -0
- package/data/seed/mappings/iso27001-dga.json +50 -0
- package/data/seed/mappings/iso27001-dma.json +50 -0
- package/data/seed/mappings/iso27001-dsa.json +58 -0
- package/data/seed/mappings/iso27001-eecc.json +74 -0
- package/data/seed/mappings/iso27001-ehds.json +90 -0
- package/data/seed/mappings/iso27001-eidas2.json +106 -0
- package/data/seed/mappings/iso27001-eprivacy.json +66 -0
- package/data/seed/mappings/iso27001-eu_taxonomy.json +34 -0
- package/data/seed/mappings/iso27001-eucc.json +66 -0
- package/data/seed/mappings/iso27001-eudr.json +34 -0
- package/data/seed/mappings/iso27001-gpsr.json +42 -0
- package/data/seed/mappings/iso27001-ivdr.json +66 -0
- package/data/seed/mappings/iso27001-led.json +74 -0
- package/data/seed/mappings/iso27001-machinery.json +50 -0
- package/data/seed/mappings/iso27001-mdr.json +82 -0
- package/data/seed/mappings/iso27001-mica.json +66 -0
- package/data/seed/mappings/iso27001-mifid2.json +66 -0
- package/data/seed/mappings/iso27001-mifir.json +42 -0
- package/data/seed/mappings/iso27001-pld.json +26 -0
- package/data/seed/mappings/iso27001-psd2.json +82 -0
- package/data/seed/mappings/iso27001-red.json +42 -0
- package/data/seed/mappings/iso27001-sfdr.json +50 -0
- package/data/seed/mappings/iso27001-un-r155.json +130 -0
- package/data/seed/mappings/iso27001-un-r156.json +106 -0
- package/data/seed/mappings/nist-csf-ai-act.json +138 -0
- package/data/seed/mappings/nist-csf-aifmd.json +58 -0
- package/data/seed/mappings/nist-csf-cbam.json +42 -0
- package/data/seed/mappings/nist-csf-cer.json +90 -0
- package/data/seed/mappings/nist-csf-cra.json +130 -0
- package/data/seed/mappings/nist-csf-csddd.json +50 -0
- package/data/seed/mappings/nist-csf-csrd.json +34 -0
- package/data/seed/mappings/nist-csf-cyber_solidarity.json +90 -0
- package/data/seed/mappings/nist-csf-cybersecurity-act.json +90 -0
- package/data/seed/mappings/nist-csf-data-act.json +50 -0
- package/data/seed/mappings/nist-csf-dga.json +58 -0
- package/data/seed/mappings/nist-csf-dma.json +42 -0
- package/data/seed/mappings/nist-csf-dora.json +210 -0
- package/data/seed/mappings/nist-csf-dsa.json +82 -0
- package/data/seed/mappings/nist-csf-eecc.json +90 -0
- package/data/seed/mappings/nist-csf-ehds.json +98 -0
- package/data/seed/mappings/nist-csf-eidas2.json +114 -0
- package/data/seed/mappings/nist-csf-eprivacy.json +58 -0
- package/data/seed/mappings/nist-csf-eu_taxonomy.json +34 -0
- package/data/seed/mappings/nist-csf-eucc.json +66 -0
- package/data/seed/mappings/nist-csf-eudr.json +58 -0
- package/data/seed/mappings/nist-csf-gdpr.json +178 -0
- package/data/seed/mappings/nist-csf-gpsr.json +58 -0
- package/data/seed/mappings/nist-csf-ivdr.json +66 -0
- package/data/seed/mappings/nist-csf-led.json +74 -0
- package/data/seed/mappings/nist-csf-machinery.json +58 -0
- package/data/seed/mappings/nist-csf-mdr.json +66 -0
- package/data/seed/mappings/nist-csf-mica.json +98 -0
- package/data/seed/mappings/nist-csf-mifid2.json +74 -0
- package/data/seed/mappings/nist-csf-mifir.json +50 -0
- package/data/seed/mappings/nist-csf-nis2.json +194 -0
- package/data/seed/mappings/nist-csf-pld.json +34 -0
- package/data/seed/mappings/nist-csf-psd2.json +98 -0
- package/data/seed/mappings/nist-csf-red.json +58 -0
- package/data/seed/mappings/nist-csf-sfdr.json +42 -0
- package/data/seed/mappings/nist-csf-un-r155.json +130 -0
- package/data/seed/mappings/nist-csf-un-r156.json +98 -0
- package/data/seed/mdr.json +1066 -0
- package/data/seed/mica.json +1003 -0
- package/data/seed/mifid2.json +906 -0
- package/data/seed/mifir.json +512 -0
- package/data/seed/pld.json +244 -0
- package/data/seed/psd2.json +827 -0
- package/data/seed/red.json +452 -0
- package/data/seed/sfdr.json +228 -0
- package/data/seed/un-r155.json +166 -0
- package/data/seed/un-r156.json +150 -0
- package/dist/http-server.d.ts +9 -0
- package/dist/http-server.d.ts.map +1 -0
- package/dist/http-server.js +342 -0
- package/dist/http-server.js.map +1 -0
- package/dist/index.js +4 -4
- package/dist/index.js.map +1 -1
- package/dist/tools/map.d.ts +1 -1
- package/dist/tools/map.d.ts.map +1 -1
- package/dist/tools/map.js +3 -3
- package/dist/tools/map.js.map +1 -1
- package/package.json +8 -3
- package/scripts/build-db.ts +20 -8
- package/scripts/check-updates.ts +141 -39
- package/scripts/ingest-eurlex.ts +9 -1
- package/scripts/ingest-unece.ts +368 -0
- package/src/http-server.ts +380 -0
- package/src/index.ts +4 -4
- package/src/tools/map.ts +4 -4
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[
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{
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"control_id": "GV.OC-01",
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"control_name": "Organizational context",
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"regulation": "EU_TAXONOMY",
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"articles": ["1", "2", "3"],
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"coverage": "full",
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"notes": "Taxonomy framework for sustainable activities"
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},
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{
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"control_id": "GV.RR-01",
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"control_name": "Organizational roles and responsibilities",
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"regulation": "EU_TAXONOMY",
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"articles": ["8", "18"],
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"coverage": "full",
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"notes": "Disclosure obligations and responsibilities"
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},
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{
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"control_id": "ID.AM-01",
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"control_name": "Inventories of assets",
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"regulation": "EU_TAXONOMY",
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"articles": ["8", "10"],
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"coverage": "partial",
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"notes": "Inventory of taxonomy-aligned activities"
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},
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{
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"control_id": "PR.DS-01",
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"control_name": "Data-at-rest is protected",
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"regulation": "EU_TAXONOMY",
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"articles": ["8"],
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"coverage": "partial",
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"notes": "Protection of taxonomy disclosure data"
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}
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"control_id": "GV.OC-01",
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"control_name": "Organizational context",
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"regulation": "EUCC",
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"articles": ["1", "2"],
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"coverage": "full",
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"notes": "Common Criteria cybersecurity certification context"
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},
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"control_id": "GV.RM-01",
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"control_name": "Risk management objectives",
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"regulation": "EUCC",
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"articles": ["3", "4"],
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"coverage": "full",
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"notes": "Security evaluation and assurance levels"
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"control_id": "GV.RR-01",
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"control_name": "Organizational roles and responsibilities",
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"regulation": "EUCC",
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"articles": ["18", "19", "20"],
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"coverage": "full",
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"notes": "NCCAs, CABs, and certification body roles"
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"control_id": "ID.RA-01",
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"control_name": "Vulnerabilities in assets are identified",
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"regulation": "EUCC",
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"articles": ["7", "8", "9"],
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"coverage": "full",
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"notes": "Vulnerability analysis during certification"
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"control_id": "ID.RA-05",
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"control_name": "Risk responses are identified",
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"regulation": "EUCC",
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"articles": ["10", "11"],
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"coverage": "full",
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"notes": "Security targets and protection profiles"
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"control_id": "PR.PS-01",
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"control_name": "Configuration management practices established",
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"regulation": "EUCC",
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"articles": ["35", "36"],
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"coverage": "full",
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"notes": "ICT product configuration management"
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"control_id": "DE.CM-01",
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"control_name": "Networks and network services are monitored",
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"regulation": "EUCC",
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"articles": ["28", "29"],
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"coverage": "partial",
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"notes": "Ongoing surveillance requirements"
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"control_id": "RS.CO-03",
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"control_name": "Information is shared with designated external parties",
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"regulation": "EUCC",
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"articles": ["28", "30"],
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"coverage": "full",
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"notes": "Vulnerability disclosure and reporting"
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}
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"control_id": "GV.OC-01",
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"control_name": "Organizational context",
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"regulation": "EUDR",
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"articles": ["1", "2"],
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"coverage": "full",
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"notes": "Deforestation-free products regulatory context"
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"control_id": "GV.RM-01",
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"control_name": "Risk management objectives",
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"regulation": "EUDR",
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"articles": ["8", "10"],
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"coverage": "full",
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"notes": "Due diligence risk assessment"
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"control_id": "GV.RR-01",
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"control_name": "Organizational roles and responsibilities",
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"regulation": "EUDR",
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"articles": ["3", "4", "5"],
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"coverage": "full",
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"notes": "Operator and trader responsibilities"
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"control_id": "GV.SC-01",
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"control_name": "Supply chain risk management program",
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"regulation": "EUDR",
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"articles": ["8", "9", "10"],
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"coverage": "full",
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"notes": "Supply chain due diligence for deforestation-free products"
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"control_name": "Inventories of assets",
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"regulation": "EUDR",
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"articles": ["9", "12"],
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"coverage": "full",
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"notes": "Geolocation data and traceability records"
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"control_id": "PR.DS-01",
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"control_name": "Data-at-rest is protected",
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"regulation": "EUDR",
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"articles": ["9"],
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"coverage": "partial",
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"notes": "Protection of supply chain traceability data"
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"control_id": "RS.CO-03",
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"control_name": "Information is shared with designated external parties",
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"regulation": "EUDR",
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"articles": ["31", "32"],
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"coverage": "full",
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"notes": "Due diligence statements and reporting"
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"control_name": "Organizational context",
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"regulation": "GDPR",
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"articles": ["1", "2", "3"],
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"coverage": "full",
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"notes": "GDPR Art 1-3 define organizational context for data protection compliance"
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"control_name": "Risk management objectives",
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"regulation": "GDPR",
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"articles": ["24", "32"],
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"coverage": "full",
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"notes": "Art 24 controller responsibility, Art 32 security of processing based on risk"
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"control_id": "GV.RR-01",
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"control_name": "Organizational roles and responsibilities",
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"regulation": "GDPR",
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"articles": ["24", "26", "37", "38", "39"],
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"coverage": "full",
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"notes": "Controller/processor responsibilities (Art 24, 26), DPO designation and tasks (Art 37-39)"
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"control_id": "GV.PO-01",
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"control_name": "Cybersecurity policy",
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"regulation": "GDPR",
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"articles": ["24", "32"],
|
|
31
|
+
"coverage": "partial",
|
|
32
|
+
"notes": "Art 24 requires appropriate policies, Art 32 security measures"
|
|
33
|
+
},
|
|
34
|
+
{
|
|
35
|
+
"control_id": "ID.AM-01",
|
|
36
|
+
"control_name": "Inventories of assets",
|
|
37
|
+
"regulation": "GDPR",
|
|
38
|
+
"articles": ["30"],
|
|
39
|
+
"coverage": "partial",
|
|
40
|
+
"notes": "Art 30 requires records of processing activities including data categories"
|
|
41
|
+
},
|
|
42
|
+
{
|
|
43
|
+
"control_id": "ID.AM-02",
|
|
44
|
+
"control_name": "Software platforms and applications inventories",
|
|
45
|
+
"regulation": "GDPR",
|
|
46
|
+
"articles": ["30", "32"],
|
|
47
|
+
"coverage": "partial",
|
|
48
|
+
"notes": "Art 30 records of processing, Art 32 implies knowledge of systems processing data"
|
|
49
|
+
},
|
|
50
|
+
{
|
|
51
|
+
"control_id": "ID.RA-01",
|
|
52
|
+
"control_name": "Vulnerabilities in assets are identified",
|
|
53
|
+
"regulation": "GDPR",
|
|
54
|
+
"articles": ["32", "35"],
|
|
55
|
+
"coverage": "partial",
|
|
56
|
+
"notes": "Art 32 risk assessment for security, Art 35 DPIA for high-risk processing"
|
|
57
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+
},
|
|
58
|
+
{
|
|
59
|
+
"control_id": "ID.RA-03",
|
|
60
|
+
"control_name": "Internal and external threats are identified",
|
|
61
|
+
"regulation": "GDPR",
|
|
62
|
+
"articles": ["32", "35"],
|
|
63
|
+
"coverage": "partial",
|
|
64
|
+
"notes": "Art 32 requires protection against threats, Art 35 threat identification in DPIA"
|
|
65
|
+
},
|
|
66
|
+
{
|
|
67
|
+
"control_id": "ID.RA-05",
|
|
68
|
+
"control_name": "Risk responses are identified",
|
|
69
|
+
"regulation": "GDPR",
|
|
70
|
+
"articles": ["32", "35"],
|
|
71
|
+
"coverage": "full",
|
|
72
|
+
"notes": "Art 32 appropriate security measures, Art 35 measures to address risks"
|
|
73
|
+
},
|
|
74
|
+
{
|
|
75
|
+
"control_id": "PR.AA-01",
|
|
76
|
+
"control_name": "Identities and credentials for authorized users",
|
|
77
|
+
"regulation": "GDPR",
|
|
78
|
+
"articles": ["25", "32"],
|
|
79
|
+
"coverage": "partial",
|
|
80
|
+
"notes": "Art 25 data protection by design, Art 32 access control as security measure"
|
|
81
|
+
},
|
|
82
|
+
{
|
|
83
|
+
"control_id": "PR.AA-03",
|
|
84
|
+
"control_name": "Users and services are authenticated",
|
|
85
|
+
"regulation": "GDPR",
|
|
86
|
+
"articles": ["32"],
|
|
87
|
+
"coverage": "partial",
|
|
88
|
+
"notes": "Art 32 requires appropriate technical measures including authentication"
|
|
89
|
+
},
|
|
90
|
+
{
|
|
91
|
+
"control_id": "PR.AA-05",
|
|
92
|
+
"control_name": "Access permissions and authorizations are managed",
|
|
93
|
+
"regulation": "GDPR",
|
|
94
|
+
"articles": ["25", "32"],
|
|
95
|
+
"coverage": "full",
|
|
96
|
+
"notes": "Art 25 data minimization by default, Art 32 access control measures"
|
|
97
|
+
},
|
|
98
|
+
{
|
|
99
|
+
"control_id": "PR.AT-01",
|
|
100
|
+
"control_name": "Awareness and training provided",
|
|
101
|
+
"regulation": "GDPR",
|
|
102
|
+
"articles": ["39", "47"],
|
|
103
|
+
"coverage": "partial",
|
|
104
|
+
"notes": "Art 39 DPO tasks include awareness, Art 47 BCR training requirements"
|
|
105
|
+
},
|
|
106
|
+
{
|
|
107
|
+
"control_id": "PR.DS-01",
|
|
108
|
+
"control_name": "Data-at-rest is protected",
|
|
109
|
+
"regulation": "GDPR",
|
|
110
|
+
"articles": ["32"],
|
|
111
|
+
"coverage": "full",
|
|
112
|
+
"notes": "Art 32 explicitly mentions encryption and pseudonymisation"
|
|
113
|
+
},
|
|
114
|
+
{
|
|
115
|
+
"control_id": "PR.DS-02",
|
|
116
|
+
"control_name": "Data-in-transit is protected",
|
|
117
|
+
"regulation": "GDPR",
|
|
118
|
+
"articles": ["32"],
|
|
119
|
+
"coverage": "full",
|
|
120
|
+
"notes": "Art 32 requires appropriate security for data transmission"
|
|
121
|
+
},
|
|
122
|
+
{
|
|
123
|
+
"control_id": "PR.DS-10",
|
|
124
|
+
"control_name": "Data is disposed of properly",
|
|
125
|
+
"regulation": "GDPR",
|
|
126
|
+
"articles": ["5", "17"],
|
|
127
|
+
"coverage": "full",
|
|
128
|
+
"notes": "Art 5 storage limitation, Art 17 right to erasure"
|
|
129
|
+
},
|
|
130
|
+
{
|
|
131
|
+
"control_id": "DE.CM-01",
|
|
132
|
+
"control_name": "Networks and network services are monitored",
|
|
133
|
+
"regulation": "GDPR",
|
|
134
|
+
"articles": ["32"],
|
|
135
|
+
"coverage": "partial",
|
|
136
|
+
"notes": "Art 32 implies monitoring as part of security measures"
|
|
137
|
+
},
|
|
138
|
+
{
|
|
139
|
+
"control_id": "DE.AE-02",
|
|
140
|
+
"control_name": "Potentially adverse events are analyzed",
|
|
141
|
+
"regulation": "GDPR",
|
|
142
|
+
"articles": ["33"],
|
|
143
|
+
"coverage": "full",
|
|
144
|
+
"notes": "Art 33 requires assessing breach impact for notification"
|
|
145
|
+
},
|
|
146
|
+
{
|
|
147
|
+
"control_id": "RS.MA-01",
|
|
148
|
+
"control_name": "Incident response plan is executed",
|
|
149
|
+
"regulation": "GDPR",
|
|
150
|
+
"articles": ["33", "34"],
|
|
151
|
+
"coverage": "full",
|
|
152
|
+
"notes": "Art 33 breach notification to authority, Art 34 notification to data subjects"
|
|
153
|
+
},
|
|
154
|
+
{
|
|
155
|
+
"control_id": "RS.CO-02",
|
|
156
|
+
"control_name": "Incidents are reported internally",
|
|
157
|
+
"regulation": "GDPR",
|
|
158
|
+
"articles": ["33"],
|
|
159
|
+
"coverage": "full",
|
|
160
|
+
"notes": "Art 33 requires internal awareness to notify within 72 hours"
|
|
161
|
+
},
|
|
162
|
+
{
|
|
163
|
+
"control_id": "RS.CO-03",
|
|
164
|
+
"control_name": "Information is shared with designated external parties",
|
|
165
|
+
"regulation": "GDPR",
|
|
166
|
+
"articles": ["33", "34"],
|
|
167
|
+
"coverage": "full",
|
|
168
|
+
"notes": "Art 33 notification to supervisory authority, Art 34 to data subjects"
|
|
169
|
+
},
|
|
170
|
+
{
|
|
171
|
+
"control_id": "RC.RP-01",
|
|
172
|
+
"control_name": "Recovery plan is executed",
|
|
173
|
+
"regulation": "GDPR",
|
|
174
|
+
"articles": ["32"],
|
|
175
|
+
"coverage": "partial",
|
|
176
|
+
"notes": "Art 32(1)(c) ability to restore availability and access to data"
|
|
177
|
+
}
|
|
178
|
+
]
|
|
@@ -0,0 +1,58 @@
|
|
|
1
|
+
[
|
|
2
|
+
{
|
|
3
|
+
"control_id": "GV.OC-01",
|
|
4
|
+
"control_name": "Organizational context",
|
|
5
|
+
"regulation": "GPSR",
|
|
6
|
+
"articles": ["1", "2", "3"],
|
|
7
|
+
"coverage": "full",
|
|
8
|
+
"notes": "General product safety regulatory context"
|
|
9
|
+
},
|
|
10
|
+
{
|
|
11
|
+
"control_id": "GV.RM-01",
|
|
12
|
+
"control_name": "Risk management objectives",
|
|
13
|
+
"regulation": "GPSR",
|
|
14
|
+
"articles": ["6", "9"],
|
|
15
|
+
"coverage": "full",
|
|
16
|
+
"notes": "Product safety risk assessment"
|
|
17
|
+
},
|
|
18
|
+
{
|
|
19
|
+
"control_id": "GV.RR-01",
|
|
20
|
+
"control_name": "Organizational roles and responsibilities",
|
|
21
|
+
"regulation": "GPSR",
|
|
22
|
+
"articles": ["9", "10", "11"],
|
|
23
|
+
"coverage": "full",
|
|
24
|
+
"notes": "Economic operator responsibilities"
|
|
25
|
+
},
|
|
26
|
+
{
|
|
27
|
+
"control_id": "GV.SC-01",
|
|
28
|
+
"control_name": "Supply chain risk management program",
|
|
29
|
+
"regulation": "GPSR",
|
|
30
|
+
"articles": ["9", "10", "11", "12"],
|
|
31
|
+
"coverage": "full",
|
|
32
|
+
"notes": "Supply chain traceability requirements"
|
|
33
|
+
},
|
|
34
|
+
{
|
|
35
|
+
"control_id": "ID.AM-01",
|
|
36
|
+
"control_name": "Inventories of assets",
|
|
37
|
+
"regulation": "GPSR",
|
|
38
|
+
"articles": ["9", "18"],
|
|
39
|
+
"coverage": "full",
|
|
40
|
+
"notes": "Product traceability and documentation"
|
|
41
|
+
},
|
|
42
|
+
{
|
|
43
|
+
"control_id": "RS.CO-03",
|
|
44
|
+
"control_name": "Information is shared with designated external parties",
|
|
45
|
+
"regulation": "GPSR",
|
|
46
|
+
"articles": ["19", "20", "21"],
|
|
47
|
+
"coverage": "full",
|
|
48
|
+
"notes": "Product safety notifications via Safety Gate"
|
|
49
|
+
},
|
|
50
|
+
{
|
|
51
|
+
"control_id": "RS.MA-01",
|
|
52
|
+
"control_name": "Incident response plan is executed",
|
|
53
|
+
"regulation": "GPSR",
|
|
54
|
+
"articles": ["19", "20"],
|
|
55
|
+
"coverage": "full",
|
|
56
|
+
"notes": "Dangerous product response procedures"
|
|
57
|
+
}
|
|
58
|
+
]
|
|
@@ -0,0 +1,66 @@
|
|
|
1
|
+
[
|
|
2
|
+
{
|
|
3
|
+
"control_id": "GV.OC-01",
|
|
4
|
+
"control_name": "Organizational context",
|
|
5
|
+
"regulation": "IVDR",
|
|
6
|
+
"articles": ["1", "2"],
|
|
7
|
+
"coverage": "full",
|
|
8
|
+
"notes": "In vitro diagnostic device regulatory context"
|
|
9
|
+
},
|
|
10
|
+
{
|
|
11
|
+
"control_id": "GV.RM-01",
|
|
12
|
+
"control_name": "Risk management objectives",
|
|
13
|
+
"regulation": "IVDR",
|
|
14
|
+
"articles": ["10", "14"],
|
|
15
|
+
"coverage": "full",
|
|
16
|
+
"notes": "Risk management for IVD devices"
|
|
17
|
+
},
|
|
18
|
+
{
|
|
19
|
+
"control_id": "GV.RR-01",
|
|
20
|
+
"control_name": "Organizational roles and responsibilities",
|
|
21
|
+
"regulation": "IVDR",
|
|
22
|
+
"articles": ["10", "11", "15"],
|
|
23
|
+
"coverage": "full",
|
|
24
|
+
"notes": "Manufacturer and authorized representative duties"
|
|
25
|
+
},
|
|
26
|
+
{
|
|
27
|
+
"control_id": "GV.SC-01",
|
|
28
|
+
"control_name": "Supply chain risk management program",
|
|
29
|
+
"regulation": "IVDR",
|
|
30
|
+
"articles": ["10", "22"],
|
|
31
|
+
"coverage": "full",
|
|
32
|
+
"notes": "Supply chain controls for IVD devices"
|
|
33
|
+
},
|
|
34
|
+
{
|
|
35
|
+
"control_id": "ID.AM-01",
|
|
36
|
+
"control_name": "Inventories of assets",
|
|
37
|
+
"regulation": "IVDR",
|
|
38
|
+
"articles": ["24", "25", "26"],
|
|
39
|
+
"coverage": "full",
|
|
40
|
+
"notes": "UDI system and device identification"
|
|
41
|
+
},
|
|
42
|
+
{
|
|
43
|
+
"control_id": "PR.DS-01",
|
|
44
|
+
"control_name": "Data-at-rest is protected",
|
|
45
|
+
"regulation": "IVDR",
|
|
46
|
+
"articles": ["100", "101"],
|
|
47
|
+
"coverage": "partial",
|
|
48
|
+
"notes": "EUDAMED database security"
|
|
49
|
+
},
|
|
50
|
+
{
|
|
51
|
+
"control_id": "RS.CO-03",
|
|
52
|
+
"control_name": "Information is shared with designated external parties",
|
|
53
|
+
"regulation": "IVDR",
|
|
54
|
+
"articles": ["82", "83", "84"],
|
|
55
|
+
"coverage": "full",
|
|
56
|
+
"notes": "Vigilance reporting and incident notification"
|
|
57
|
+
},
|
|
58
|
+
{
|
|
59
|
+
"control_id": "RS.MA-01",
|
|
60
|
+
"control_name": "Incident response plan is executed",
|
|
61
|
+
"regulation": "IVDR",
|
|
62
|
+
"articles": ["82", "83"],
|
|
63
|
+
"coverage": "full",
|
|
64
|
+
"notes": "Serious incident reporting procedures"
|
|
65
|
+
}
|
|
66
|
+
]
|
|
@@ -0,0 +1,74 @@
|
|
|
1
|
+
[
|
|
2
|
+
{
|
|
3
|
+
"control_id": "GV.OC-01",
|
|
4
|
+
"control_name": "Organizational context",
|
|
5
|
+
"regulation": "LED",
|
|
6
|
+
"articles": ["1", "2", "3"],
|
|
7
|
+
"coverage": "full",
|
|
8
|
+
"notes": "Law enforcement data processing context"
|
|
9
|
+
},
|
|
10
|
+
{
|
|
11
|
+
"control_id": "GV.RR-01",
|
|
12
|
+
"control_name": "Organizational roles and responsibilities",
|
|
13
|
+
"regulation": "LED",
|
|
14
|
+
"articles": ["19", "20", "21"],
|
|
15
|
+
"coverage": "full",
|
|
16
|
+
"notes": "Controller and processor responsibilities"
|
|
17
|
+
},
|
|
18
|
+
{
|
|
19
|
+
"control_id": "GV.PO-01",
|
|
20
|
+
"control_name": "Cybersecurity policy",
|
|
21
|
+
"regulation": "LED",
|
|
22
|
+
"articles": ["29", "30"],
|
|
23
|
+
"coverage": "full",
|
|
24
|
+
"notes": "Security of processing policies"
|
|
25
|
+
},
|
|
26
|
+
{
|
|
27
|
+
"control_id": "PR.AA-01",
|
|
28
|
+
"control_name": "Identities and credentials for authorized users",
|
|
29
|
+
"regulation": "LED",
|
|
30
|
+
"articles": ["29"],
|
|
31
|
+
"coverage": "full",
|
|
32
|
+
"notes": "Access controls for law enforcement data"
|
|
33
|
+
},
|
|
34
|
+
{
|
|
35
|
+
"control_id": "PR.AA-05",
|
|
36
|
+
"control_name": "Access permissions and authorizations are managed",
|
|
37
|
+
"regulation": "LED",
|
|
38
|
+
"articles": ["12", "29"],
|
|
39
|
+
"coverage": "full",
|
|
40
|
+
"notes": "Differentiation between categories of personal data"
|
|
41
|
+
},
|
|
42
|
+
{
|
|
43
|
+
"control_id": "PR.DS-01",
|
|
44
|
+
"control_name": "Data-at-rest is protected",
|
|
45
|
+
"regulation": "LED",
|
|
46
|
+
"articles": ["29"],
|
|
47
|
+
"coverage": "full",
|
|
48
|
+
"notes": "Security of stored law enforcement data"
|
|
49
|
+
},
|
|
50
|
+
{
|
|
51
|
+
"control_id": "PR.DS-02",
|
|
52
|
+
"control_name": "Data-in-transit is protected",
|
|
53
|
+
"regulation": "LED",
|
|
54
|
+
"articles": ["29", "35"],
|
|
55
|
+
"coverage": "full",
|
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56
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+
"notes": "Security of data transfers"
|
|
57
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+
},
|
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58
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+
{
|
|
59
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+
"control_id": "DE.CM-01",
|
|
60
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+
"control_name": "Networks and network services are monitored",
|
|
61
|
+
"regulation": "LED",
|
|
62
|
+
"articles": ["29"],
|
|
63
|
+
"coverage": "full",
|
|
64
|
+
"notes": "Logging and monitoring requirements"
|
|
65
|
+
},
|
|
66
|
+
{
|
|
67
|
+
"control_id": "RS.CO-03",
|
|
68
|
+
"control_name": "Information is shared with designated external parties",
|
|
69
|
+
"regulation": "LED",
|
|
70
|
+
"articles": ["30", "31"],
|
|
71
|
+
"coverage": "full",
|
|
72
|
+
"notes": "Personal data breach notification"
|
|
73
|
+
}
|
|
74
|
+
]
|
|
@@ -0,0 +1,58 @@
|
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1
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+
[
|
|
2
|
+
{
|
|
3
|
+
"control_id": "GV.OC-01",
|
|
4
|
+
"control_name": "Organizational context",
|
|
5
|
+
"regulation": "MACHINERY",
|
|
6
|
+
"articles": ["1", "2", "3"],
|
|
7
|
+
"coverage": "full",
|
|
8
|
+
"notes": "Machinery and related products regulatory context"
|
|
9
|
+
},
|
|
10
|
+
{
|
|
11
|
+
"control_id": "GV.RM-01",
|
|
12
|
+
"control_name": "Risk management objectives",
|
|
13
|
+
"regulation": "MACHINERY",
|
|
14
|
+
"articles": ["5", "10"],
|
|
15
|
+
"coverage": "full",
|
|
16
|
+
"notes": "Risk assessment and risk reduction for machinery"
|
|
17
|
+
},
|
|
18
|
+
{
|
|
19
|
+
"control_id": "GV.RR-01",
|
|
20
|
+
"control_name": "Organizational roles and responsibilities",
|
|
21
|
+
"regulation": "MACHINERY",
|
|
22
|
+
"articles": ["10", "11", "12", "13"],
|
|
23
|
+
"coverage": "full",
|
|
24
|
+
"notes": "Manufacturer and economic operator obligations"
|
|
25
|
+
},
|
|
26
|
+
{
|
|
27
|
+
"control_id": "GV.SC-01",
|
|
28
|
+
"control_name": "Supply chain risk management program",
|
|
29
|
+
"regulation": "MACHINERY",
|
|
30
|
+
"articles": ["10", "11", "12"],
|
|
31
|
+
"coverage": "full",
|
|
32
|
+
"notes": "Supply chain obligations for machinery"
|
|
33
|
+
},
|
|
34
|
+
{
|
|
35
|
+
"control_id": "ID.AM-01",
|
|
36
|
+
"control_name": "Inventories of assets",
|
|
37
|
+
"regulation": "MACHINERY",
|
|
38
|
+
"articles": ["10"],
|
|
39
|
+
"coverage": "partial",
|
|
40
|
+
"notes": "Technical documentation requirements"
|
|
41
|
+
},
|
|
42
|
+
{
|
|
43
|
+
"control_id": "PR.DS-01",
|
|
44
|
+
"control_name": "Data-at-rest is protected",
|
|
45
|
+
"regulation": "MACHINERY",
|
|
46
|
+
"articles": ["5"],
|
|
47
|
+
"coverage": "partial",
|
|
48
|
+
"notes": "Digital components data protection"
|
|
49
|
+
},
|
|
50
|
+
{
|
|
51
|
+
"control_id": "RS.CO-03",
|
|
52
|
+
"control_name": "Information is shared with designated external parties",
|
|
53
|
+
"regulation": "MACHINERY",
|
|
54
|
+
"articles": ["43", "44"],
|
|
55
|
+
"coverage": "full",
|
|
56
|
+
"notes": "Non-compliance reporting to authorities"
|
|
57
|
+
}
|
|
58
|
+
]
|
|
@@ -0,0 +1,66 @@
|
|
|
1
|
+
[
|
|
2
|
+
{
|
|
3
|
+
"control_id": "GV.OC-01",
|
|
4
|
+
"control_name": "Organizational context",
|
|
5
|
+
"regulation": "MDR",
|
|
6
|
+
"articles": ["1", "2"],
|
|
7
|
+
"coverage": "full",
|
|
8
|
+
"notes": "Medical device regulatory context"
|
|
9
|
+
},
|
|
10
|
+
{
|
|
11
|
+
"control_id": "GV.RM-01",
|
|
12
|
+
"control_name": "Risk management objectives",
|
|
13
|
+
"regulation": "MDR",
|
|
14
|
+
"articles": ["10", "14"],
|
|
15
|
+
"coverage": "full",
|
|
16
|
+
"notes": "Risk management for medical devices"
|
|
17
|
+
},
|
|
18
|
+
{
|
|
19
|
+
"control_id": "GV.RR-01",
|
|
20
|
+
"control_name": "Organizational roles and responsibilities",
|
|
21
|
+
"regulation": "MDR",
|
|
22
|
+
"articles": ["10", "11", "15"],
|
|
23
|
+
"coverage": "full",
|
|
24
|
+
"notes": "Manufacturer and authorized representative duties"
|
|
25
|
+
},
|
|
26
|
+
{
|
|
27
|
+
"control_id": "GV.SC-01",
|
|
28
|
+
"control_name": "Supply chain risk management program",
|
|
29
|
+
"regulation": "MDR",
|
|
30
|
+
"articles": ["10", "25"],
|
|
31
|
+
"coverage": "full",
|
|
32
|
+
"notes": "Supply chain controls for medical devices"
|
|
33
|
+
},
|
|
34
|
+
{
|
|
35
|
+
"control_id": "ID.AM-01",
|
|
36
|
+
"control_name": "Inventories of assets",
|
|
37
|
+
"regulation": "MDR",
|
|
38
|
+
"articles": ["27", "28", "29"],
|
|
39
|
+
"coverage": "full",
|
|
40
|
+
"notes": "UDI system and device identification"
|
|
41
|
+
},
|
|
42
|
+
{
|
|
43
|
+
"control_id": "PR.DS-01",
|
|
44
|
+
"control_name": "Data-at-rest is protected",
|
|
45
|
+
"regulation": "MDR",
|
|
46
|
+
"articles": ["110", "111"],
|
|
47
|
+
"coverage": "partial",
|
|
48
|
+
"notes": "EUDAMED database security"
|
|
49
|
+
},
|
|
50
|
+
{
|
|
51
|
+
"control_id": "RS.CO-03",
|
|
52
|
+
"control_name": "Information is shared with designated external parties",
|
|
53
|
+
"regulation": "MDR",
|
|
54
|
+
"articles": ["87", "88", "89"],
|
|
55
|
+
"coverage": "full",
|
|
56
|
+
"notes": "Vigilance reporting and incident notification"
|
|
57
|
+
},
|
|
58
|
+
{
|
|
59
|
+
"control_id": "RS.MA-01",
|
|
60
|
+
"control_name": "Incident response plan is executed",
|
|
61
|
+
"regulation": "MDR",
|
|
62
|
+
"articles": ["87", "88"],
|
|
63
|
+
"coverage": "full",
|
|
64
|
+
"notes": "Serious incident reporting procedures"
|
|
65
|
+
}
|
|
66
|
+
]
|