PMPF Plan & Report (IVDR)

IVDR reference: Annex XIII Part B; continuous update of performance evaluation (Art. 56)
Document code: PMPF

Checklist

• [ ] PMPF plan: objectives, methods, data sources, metrics, statistics, milestones, responsibilities
• [ ] Plan addresses residual uncertainties / knowledge gaps from the PER
• [ ] Data sources may include routine diagnostic use, registries, literature, complaints/vigilance, dedicated studies
• [ ] PMPF report: results, impact on PE / IFU / RM, follow-up actions
• [ ] Clear interface with the PMS plan
• [ ] Intensity proportionate to risk (notably class C/D and high-risk claims)

Related pages

• Performance evaluation
• PMS
• SSP