{
  "note": "Generated by `npm run rdr-contract` in the eudamate repo. Do not edit by hand. Vendored to eudamate-landing/src/data/rdr-spec-contract.json.",
  "rdrVersion": "2.2",
  "title": "Registration Decision Record",
  "headings": {
    "inEveryRecord": [
      "Summary",
      "Files and audit trail",
      "Approval",
      "Exceptions recorded at export",
      "State of the values at the time of this record",
      "Devices in this record",
      "Audit trail check",
      "Audit chain head",
      "XSD schema check",
      "How to read the EMDN classification",
      "How this record relates to ISO 13485:2016",
      "1. Data Provenance",
      "2. Column Mapping",
      "3. EMDN Classification",
      "3.5 Field-Level Reasoning",
      "4. Human Overrides",
      "5. Validation History",
      "6. Milestones",
      "7. Full Timeline"
    ],
    "generatorCanWrite": [
      "3.7 Storage and handling conditions and critical warnings",
      "3.6 Substances",
      "XSD schema check",
      "Audit trail check",
      "Audit chain head",
      "Project statement about CMR and endocrine-disrupting substances",
      "Project decisions about the language of texts",
      "How to read the EMDN classification",
      "How this record relates to ISO 13485:2016",
      "6.5 Repeating Groups",
      "1. Data Provenance",
      "2. Column Mapping",
      "3. EMDN Classification",
      "3.5 Field-Level Reasoning",
      "4. Human Overrides",
      "5. Validation History",
      "6. Milestones",
      "7. Full Timeline",
      "Exceptions recorded at export",
      "State of the values at the time of this record",
      "Devices in this record",
      "4.1 Change history",
      "Change capture",
      "Bulk reviews",
      "Devices removed",
      "Summary",
      "Files and audit trail",
      "Approval",
      "XML files made at export",
      "EUDAMED results",
      "EUDAMED results recorded"
    ]
  },
  "verdicts": [
    "Intact",
    "NOT INTACT",
    "NO AUDIT TRAIL",
    "UNKNOWN"
  ],
  "chainIntactText": "The application's database refuses changes to audit events and deletes them only when the project's data is deleted under the retention policy. The stored hashes link each event to the one before it. The check found no event that was altered or reordered since it was written, as far as the stored hashes show.",
  "statusLabels": [
    "Ready",
    "Needs review",
    "Not ready",
    "Approved",
    "Changed by reviewer",
    "Left empty by reviewer",
    "Not required"
  ],
  "sourceLabels": [
    {
      "method": "exact",
      "label": "Exact column match"
    },
    {
      "method": "normalised",
      "label": "Column match after normalising the name"
    },
    {
      "method": "alias",
      "label": "Column match by alias"
    },
    {
      "method": "ai",
      "label": "AI column mapping"
    },
    {
      "method": "ai-classified",
      "label": "AI suggestion"
    },
    {
      "method": "ai-inferred",
      "label": "AI inference"
    },
    {
      "method": "override",
      "label": "Changed by reviewer"
    },
    {
      "method": "manual",
      "label": "Entered by reviewer"
    },
    {
      "method": "approved",
      "label": "Approved by reviewer"
    },
    {
      "method": "auto-approved",
      "label": "Approved in bulk"
    },
    {
      "method": "left-empty",
      "label": "Left empty by reviewer"
    },
    {
      "method": "derived",
      "label": "Derived by rule"
    },
    {
      "method": "declared",
      "label": "Declared by the customer"
    },
    {
      "method": "unmapped",
      "label": "Not mapped"
    },
    {
      "method": "pending",
      "label": "Pending"
    },
    {
      "method": "conflict",
      "label": "Conflicting sources"
    },
    {
      "method": "legislation-column",
      "label": "Column chosen by the device's legislation"
    },
    {
      "method": "sibling-applied",
      "label": "Copied from a sibling device"
    },
    {
      "method": "certificate-extracted",
      "label": "Read from a certificate"
    },
    {
      "method": "eudamed-neighbours",
      "label": "From similar EUDAMED registrations"
    },
    {
      "method": "reprocessed",
      "label": "Reprocessing declaration"
    },
    {
      "method": "regex",
      "label": "Pattern match"
    },
    {
      "method": "locked",
      "label": "Locked"
    }
  ],
  "reasonLabels": [
    "EUDAMED DI format suggestion",
    "Data correction",
    "Nomenclature ambiguity",
    "Source data preferred",
    "Regulatory requirement",
    "Expert judgment",
    "Other",
    "Correction by reviewer, no reason given",
    "Manual column mapping",
    "Project answer applied",
    "Project answer reset",
    "Project answer applied again",
    "Language set for every text without one",
    "Filled in bulk where the source file had no value",
    "Certificate entry added",
    "Certificate entry removed",
    "Declared no certificates",
    "No-certificates declaration withdrawn",
    "Copied from a sibling device"
  ],
  "milestoneLabels": [
    "Snapshot at upload",
    "Snapshot at export",
    "Snapshot after review",
    "Snapshot at final approval"
  ],
  "eventLabels": [
    "File uploaded",
    "Rows imported",
    "Columns mapped",
    "Validation at upload",
    "Validation at export",
    "AI EMDN suggestion",
    "Value changed",
    "Snapshot",
    "XSD format check run",
    "Legislation determined",
    "Certificate read",
    "Documents read by AI",
    "Bulk review",
    "Project answer",
    "Language set for texts without one",
    "Certificate sheet imported",
    "EUDAMED result recorded by an account",
    "Field change",
    "Device imported",
    "Device removed",
    "Bulk review completed"
  ],
  "isoLeadIn": "This record supports the manufacturer's QMS. It does not by itself demonstrate conformity with ISO 13485:2016 or any regulation.",
  "isoRows": [
    {
      "clause": "4.2.5 Control of records",
      "text": "Supports your control of records. This record can be kept under your procedure for control of records. Identification, storage, protection, retention time and disposal stay under that procedure."
    },
    {
      "clause": "4.2.3 Medical device file",
      "text": "Supports your medical device file. It can be referenced there as the record of how the EUDAMED registration data for these devices were prepared and reviewed."
    },
    {
      "clause": "7.5.8 Identification",
      "text": "Supports the documentation of how UDI-related identifiers (Basic UDI-DI, UDI-DI, EUDAMED DI) and their registration data were derived from your source data and reviewed."
    },
    {
      "clause": "4.1.6 Validation of software used in the QMS",
      "text": "Supports your validation of EUDAMate as software used in your QMS processes. Validation proportionate to risk is your responsibility. The validation results recorded here can be used as evidence in that validation."
    }
  ]
}