{
  "schemaVersion": 1,
  "datasetId": "ki-medizinproduktmonitor-eu",
  "materialFingerprint": "09fc8ec4c411091323316b53356f20d9d596d3ddb23c985ca986bd11274a4777",
  "cohort": "EUDAMED devices whose SPECIAL_DEVICE_TYPE_ID resolves exactly to Software",
  "rules": {
    "sourceFieldsOnly": true,
    "aiEvidence": "Exact terms in TRADE_NAME, DEVICE_NAME, DEVICE_MODEL, REFERENCE or MEDICAL_PURPOSE only.",
    "softwareIsNotAi": true,
    "manufacturerIsNotAiEvidence": true,
    "firstAndLastObservedAreCollectorObservations": true,
    "lifecycleEventTimesAreCollectorObservations": true,
    "lifecycleLedgerIsBounded": true,
    "sourceChangeDateClaimed": false,
    "certificateLanePublished": false,
    "marketSurveillanceLanePublished": false
  },
  "evidenceTiers": [
    {
      "id": "explicit",
      "rank": 1,
      "label": {
        "de": "expliziter KI-Begriff",
        "en": "explicit AI term"
      }
    },
    {
      "id": "contextual_ai_token",
      "rank": 2,
      "label": {
        "de": "eigenständiges AI-Token im Kontextfeld",
        "en": "standalone AI token in a contextual field"
      }
    },
    {
      "id": "brand_only",
      "rank": 3,
      "label": {
        "de": "AI nur im Marken-, Modell- oder Referenzfeld",
        "en": "AI only in a brand, model or reference field"
      }
    }
  ],
  "lifecycle": {
    "timeBasis": "collector_observation",
    "sourceChangeDatesAvailable": false,
    "totalEventCount": 30,
    "retainedEventCount": 21,
    "truncated": true
  },
  "publicFields": [
    "PRIMARY_DI",
    "BASIC_UDI",
    "TRADE_NAME",
    "REFERENCE",
    "LATEST_VERSION",
    "VERSION_NUMBER",
    "DEVICE_NAME",
    "DEVICE_MODEL",
    "RISK_CLASS_ID",
    "APPLICABLE_LEGISLATION_ID",
    "DEVICE_CRITERION",
    "NOMENCLATURE_CODE",
    "MF_SRN",
    "MF_NAME",
    "DEVICE_STATUS_TYPE_ID",
    "SPECIAL_DEVICE_TYPE_ID",
    "STATUS_ID",
    "MEDICAL_PURPOSE",
    "ACTIVE",
    "SUBSTATUSES",
    "KIT",
    "STERILE",
    "IMPLANTABLE",
    "MEASURING_FUNCTION",
    "SELF_TESTING",
    "REAGENT",
    "INSTRUMENT",
    "PROFESSIONAL_TESTING",
    "NEAR_PATIENT_TESTING",
    "COMPANION_DIAGNOSTICS"
  ],
  "sources": [
    {
      "id": "eudamed-public-api",
      "name": "European Commission · EUDAMED Public API",
      "url": "https://developer.datalake.sante.service.ec.europa.eu/apis",
      "apiBase": "https://api.datalake.sante.service.ec.europa.eu/eudamed"
    },
    {
      "id": "eudamed-overview",
      "name": "European Commission · EUDAMED overview",
      "url": "https://health.ec.europa.eu/medical-devices-eudamed/overview_en"
    },
    {
      "id": "eudamed-api-guide",
      "name": "European Commission · Public API user guide",
      "url": "https://webgate.ec.europa.eu/eudamed-play-help/en/files/Public%20API%20-%20user%20guide.pdf"
    },
    {
      "id": "commission-legal-notice",
      "name": "European Commission · Legal notice",
      "url": "https://commission.europa.eu/legal-notice_en"
    }
  ],
  "rights": {
    "notice": "https://commission.europa.eu/legal-notice_en",
    "attribution": "European Commission, EUDAMED Public API; transformed by i6eal with exact-field evidence tiers and observation timestamps disclosed separately.",
    "noUnqualifiedDatasetLicenceClaim": true
  }
}