Per-institution + consolidated master Technical File completeness. Gate cannot advance with unmapped or unapproved required items (UC-19).
🔒 MDR / Technical File · Coordination layer
🔒 Coordination layer, not the DHF system of record (CF-114). Completeness is computed from the RegulatedPackage model (RegulatedPackage → RegulatedPackageSection → DeliverablePackageMapping). The deprecated DHF Yes/No flag is retired (PSF-004). N/A classification requires a ≥20-char justification (CF-117).