Post-Market Surveillance (PMS) (IVDR)

IVDR reference: Arts. 78–81 et al.; Annex III
Related documents: PMS plan; periodic updates (e.g. PSUR where applicable)

Checklist

• [ ] PMS plan: data sources, methods, metrics, thresholds, responsibilities, reporting pathways
• [ ] Active and passive collection: complaints, vigilance, literature, databases, PMPF, real-world data, …
• [ ] Closed loop with RM, performance-evaluation updates and CAPA
• [ ] Trend analysis and signal detection methods documented
• [ ] Reporting obligations and timelines (serious incidents, FSCA, …) procedurally ready
• [ ] Outputs feed IFU/labels, DD, PER and GSPR evidence maintenance

Related pages

• PMPF
• Performance evaluation
• Risk management