@ansvar/eu-regulations-mcp 0.1.0 → 0.2.1

package/data/seed/applicability/eucc.json

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+[
+  {
+    "regulation": "EUCC",
+    "sector": "digital_infrastructure",
+    "subsector": null,
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "EUCC establishes cybersecurity certification for ICT products"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "manufacturing",
+    "subsector": "ict_products",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Manufacturers of ICT products can seek EUCC certification"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "public_administration",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Public sector may require EUCC certified products in procurement"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "financial",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Financial sector may require certified ICT products under DORA"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Healthcare may require certified ICT products for sensitive systems"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "energy",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Critical infrastructure may require certified products under NIS2"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "transport",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Transport sector may require certified ICT products"
+  },
+  {
+    "regulation": "EUCC",
+    "sector": "other",
+    "subsector": "certification_bodies",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "5",
+    "notes": "Conformity assessment bodies must be accredited to issue EUCC certificates"
+  }
+]

package/data/seed/applicability/eudr.json

@@ -0,0 +1,74 @@
+[
+  {
+    "regulation": "EUDR",
+    "sector": "manufacturing",
+    "subsector": "food",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Food manufacturers using relevant commodities must conduct due diligence"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "manufacturing",
+    "subsector": "furniture",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Wood-based product manufacturers must comply"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "manufacturing",
+    "subsector": "rubber",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Rubber product manufacturers must conduct due diligence"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "other",
+    "subsector": "importers",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Importers of cattle, cocoa, coffee, oil palm, rubber, soya, wood must comply"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "other",
+    "subsector": "traders",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Traders of covered commodities have due diligence obligations"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "digital_infrastructure",
+    "subsector": "online_marketplaces",
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Online marketplaces selling covered products may have obligations"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "financial",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Financial sector not directly in scope"
+  },
+  {
+    "regulation": "EUDR",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Healthcare sector not in scope"
+  }
+]

package/data/seed/applicability/gpsr.json

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+[
+  {
+    "regulation": "GPSR",
+    "sector": "manufacturing",
+    "subsector": null,
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "GPSR applies to manufacturers of consumer products placed on EU market"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "manufacturing",
+    "subsector": "consumer_goods",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "All consumer products must meet general safety requirements"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "digital_infrastructure",
+    "subsector": "online_marketplaces",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "22",
+    "notes": "Online marketplaces have specific obligations under GPSR"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "other",
+    "subsector": "importers",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "11",
+    "notes": "Importers have specific verification and documentation obligations"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "other",
+    "subsector": "distributors",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "12",
+    "notes": "Distributors must verify product compliance before making available"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "financial",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Financial services not in scope"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Medical devices have separate regulation (MDR)"
+  },
+  {
+    "regulation": "GPSR",
+    "sector": "public_administration",
+    "subsector": null,
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "26",
+    "notes": "Market surveillance authorities enforce GPSR"
+  }
+]

package/data/seed/applicability/ivdr.json

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+[
+  {
+    "regulation": "IVDR",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "IVDR regulates in vitro diagnostic medical devices for human use"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "healthcare",
+    "subsector": "laboratories",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Clinical laboratories using IVD devices are within scope"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "manufacturing",
+    "subsector": "diagnostics",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Manufacturers of IVD devices must obtain CE marking and comply with IVDR"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "digital_infrastructure",
+    "subsector": "software",
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "2",
+    "notes": "Software intended for IVD purposes is covered"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "financial",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Financial sector not in scope"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "energy",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Energy sector not in scope"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "other",
+    "subsector": "research",
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Research-use only products are explicitly excluded from IVDR scope"
+  },
+  {
+    "regulation": "IVDR",
+    "sector": "other",
+    "subsector": "importers_distributors",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Importers and distributors of IVD devices have specific obligations"
+  }
+]

package/data/seed/applicability/led.json

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+[
+  {
+    "regulation": "LED",
+    "sector": "public_administration",
+    "subsector": "law_enforcement",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "LED applies to competent authorities processing data for law enforcement purposes"
+  },
+  {
+    "regulation": "LED",
+    "sector": "public_administration",
+    "subsector": "judiciary",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Courts and judicial authorities processing criminal data are covered"
+  },
+  {
+    "regulation": "LED",
+    "sector": "financial",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Private sector covered by GDPR, not LED (except when acting for law enforcement)"
+  },
+  {
+    "regulation": "LED",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Healthcare sector covered by GDPR, not LED"
+  },
+  {
+    "regulation": "LED",
+    "sector": "digital_infrastructure",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Private digital services covered by GDPR, not LED"
+  },
+  {
+    "regulation": "LED",
+    "sector": "energy",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Energy sector covered by GDPR, not LED"
+  },
+  {
+    "regulation": "LED",
+    "sector": "transport",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Transport sector covered by GDPR, not LED"
+  },
+  {
+    "regulation": "LED",
+    "sector": "other",
+    "subsector": "private_security",
+    "applies": false,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Private security firms typically covered by GDPR unless acting for authorities"
+  }
+]

package/data/seed/applicability/machinery.json

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+[
+  {
+    "regulation": "MACHINERY",
+    "sector": "manufacturing",
+    "subsector": "machinery",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Machinery Regulation applies to manufacturers of machinery and related products"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "manufacturing",
+    "subsector": "industrial_equipment",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Industrial equipment manufacturers must ensure CE marking compliance"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "digital_infrastructure",
+    "subsector": "software",
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "2",
+    "notes": "Safety software for machinery is in scope; AI systems in machinery covered"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "transport",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "2",
+    "notes": "Transport equipment may be covered unless excluded by sector-specific rules"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "energy",
+    "subsector": null,
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "2",
+    "notes": "Energy generation equipment (turbines, generators) covered"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "other",
+    "subsector": "importers",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "14",
+    "notes": "Importers must verify conformity before placing on market"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "financial",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Financial sector not in scope"
+  },
+  {
+    "regulation": "MACHINERY",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Medical devices have separate regulation (MDR)"
+  }
+]

package/data/seed/applicability/mdr.json

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+[
+  {
+    "regulation": "MDR",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "MDR regulates medical devices used in healthcare settings"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "healthcare",
+    "subsector": "hospitals",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "5",
+    "notes": "Health institutions using medical devices must ensure compliance"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "manufacturing",
+    "subsector": "medical_devices",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Manufacturers of medical devices must obtain CE marking"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "digital_infrastructure",
+    "subsector": "software",
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "2",
+    "notes": "Software as a Medical Device (SaMD) falls under MDR"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "financial",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Financial sector not in scope of medical device regulation"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "energy",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Energy sector not in scope"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "transport",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Transport sector not in scope"
+  },
+  {
+    "regulation": "MDR",
+    "sector": "other",
+    "subsector": "importers_distributors",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Importers and distributors of medical devices have specific obligations"
+  }
+]

package/data/seed/applicability/mica.json

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+[
+  {
+    "regulation": "MICA",
+    "sector": "financial",
+    "subsector": "crypto_assets",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "MiCA regulates crypto-asset service providers and issuers"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "financial",
+    "subsector": "exchanges",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Crypto exchanges must be authorized as CASPs"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "financial",
+    "subsector": "banks",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Credit institutions can provide crypto-asset services under MiCA"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "digital_infrastructure",
+    "subsector": "blockchain",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Blockchain/DLT infrastructure providers offering crypto services are in scope"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Healthcare sector not in scope"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "energy",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Energy sector not in scope"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "manufacturing",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Manufacturing sector not in scope"
+  },
+  {
+    "regulation": "MICA",
+    "sector": "other",
+    "subsector": "stablecoin_issuers",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "16",
+    "notes": "Asset-referenced token and e-money token issuers have specific requirements"
+  }
+]

package/data/seed/applicability/mifid2.json

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+[
+  {
+    "regulation": "MIFID2",
+    "sector": "financial",
+    "subsector": "investment_firms",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "MiFID II regulates investment firms and investment services"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "financial",
+    "subsector": "banks",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Credit institutions providing investment services must comply"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "financial",
+    "subsector": "trading_venues",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Regulated markets, MTFs, and OTFs are covered"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "digital_infrastructure",
+    "subsector": "data_providers",
+    "applies": true,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Data reporting services providers are regulated"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "healthcare",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Healthcare sector not in scope"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "energy",
+    "subsector": "commodity_trading",
+    "applies": true,
+    "confidence": "likely",
+    "basis_article": "1",
+    "notes": "Energy firms trading commodity derivatives may be in scope"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "manufacturing",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "1",
+    "notes": "Manufacturing sector not in scope unless trading financial instruments"
+  },
+  {
+    "regulation": "MIFID2",
+    "sector": "other",
+    "subsector": null,
+    "applies": false,
+    "confidence": "definite",
+    "basis_article": "2",
+    "notes": "Various exemptions exist for certain entities and activities"
+  }
+]