Incident Reporting Forms

Forms for reporting serious adverse events

• Vigilance Form User Manual – language version: czech / english.

Manufacturer Incident Report (MIR) Form for Serious Incidents (MDR/IVDR) / Manufacturer Incident Report (MIR) Form for Serious Incidents (MDR/IVDR)

Reporting Type:

• Initial Report – Language version: czech / english
• Follow-up Report – language version: czech / english
• Combined Initial and Final Report – language version: czech / english
• Final Report (Reportable incident) – language version: czech / english
• Final Report (Non-reportable incident) – language version: czech / english
• New Manufacturer Incident Report (MIR) New Manufacturer Incident Report (MIR) Form – verze 7.2.1, od ledna 2020.