UDI-Labeling- und Traceability-Fehler führen zu Rückrufen und Garantieansprüchen

Key Findings

• Financial Impact: Recall cost per device: €50–€300 per unit (material, logistics, customer service); estimated recall scope for mid-sized manufacturer: 5,000–50,000 units per event → €250,000–€15,000,000 total cost. Manual UDI-PI validation and label rework: 40–80 hours per production batch (€2,400–€4,800 at €60/hour). Vigilance reporting delays: €5,000–€25,000 BfArM penalty per incident (estimated); customer refunds due to authenticity/date verification failures: 1–3% of annual revenue (€100,000–€500,000 for mid-sized device maker).
• Frequency: Class I and Class II device label compliance audits: annually; recalls triggered by UDI traceability failures: 1–3 per year per manufacturer; vigilance reporting submissions: ongoing quarterly or per incident.
• Root Cause: Manual UDI-PI generation in spreadsheets or unvalidated systems; no real-time linkage between production batch records, UDI-PI assignment, and AIDC label printing. Label design changes require manual re-validation against ISO/IEC and MDR Annex VI standards. No automated vigilance report generation from complaint/adverse event database to EUDAMED's VGL module. Post-market surveillance data is siloed in separate systems (ERP, CRM, complaint tracking) and not integrated with EUDAMED reporting.