Manufacturer Incident Report

Download a free template (MS Word)

Manufacturer Incident Report (MIR) is required for all manufacturers of medical devices put on the EU market, and is used for submitting any incident involving a medical device. This template is aligned with the European Union Medical Device Vigilance System and comes with additional valuable comments that facilitate filling out the information.

This Manufacturer Incident Report for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) helps manufacturers in:

  • Identifying trends, analyzing the root cause of an incident, and making crucial adjustments to prevent similar incidents
  • Determining patterns of recurring issues that could be indicative of an underlying problem
  • Improving risk management
EU_MDR_Manufacturer_Incident_Report

 

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