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Homepage Pharmaceutical Industry Medical devices Vigilance Reporting – Medical Devices Serious Incident Reporting Forms

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:

In accordance with Article 87(9) of the MDR  or Article 82(9) of the IVDR, the manufacturer may, in agreement with the Institute, as the competent authority, for similar serious adverse events that occur in connection with the same device or type of device and for which the root cause has been identified or a field safety corrective action has been taken, or if the adverse events are frequent (common – applies to in vitro diagnostic medical devices) and well-documented, instead of individual reports of serious adverse events, provide regular summary reports through the form that shall be submitted to the Institute in a manner analogous to that of the serious incident report form, i.e., in the PDF format along with the completed data file in the XML format, either via the web interface or by means of a data message or electronic mail.

The agreement with the manufacturer includes the format, content, and frequency of this regular summary reporting.

Manufacturer’s Periodic Summary Report (PSR) Form

Manufacturer’s Periodic Summary Report (PSR) Form

Periodic summary report form

Report type:

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