BfArM-Nachweispflichten bei Kalibrierungsfehlern
Definition
Optometrists handling Class IIa ophthalmic devices (e.g., contact lens fitting equipment) require precise calibration logging under MPDG §86 (DMIDS database) and EU MDR post-market surveillance. Manual processes risk non-conformance in BfArM inspections, triggering fines or market withdrawal.
Key Findings
- Financial Impact: €5,000-50,000 per audit failure; 20-40 hours/month manual logging at €50/hour
- Frequency: Annual BfArM audits; EUDAMED/DMIDS reporting by 2022 deadline missed
- Root Cause: Manual logging incompatible with digital evidence requirements (GoBD, MPDG vigilance)
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Optometrists.
Affected Stakeholders
Optiker-Praxen, Gerätebetreiber, PRRC (Person Responsible for Regulatory Compliance)
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Reklamationskosten durch unkalibrierte Messgeräte
Ausfallzeiten durch fehlende Wartungsnachweise
Manuelle Nachbestellzeiten
Kapazitätsverlust durch manuelles Inventarmanagement
Umsatzverlust durch Inventarfehler bei Contact Linsen
Inventar-Diebstahl und -Schwund bei Brillen und Linsen
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