Free template (MS Word)
Manufacturer Incident Report
Report medical-device incidents clearly and improve investigation and risk management.
The Manufacturer Incident Report (MIR) is required for manufacturers of medical devices placed on the EU market and is used to submit incidents involving medical devices. The template aligns with the European Union Medical Device Vigilance System and includes comments that help users complete the required information.
This template helps you:
- Identify trends and analyze incident root causes
- Make adjustments that help prevent similar incidents
- Recognize recurring patterns that may indicate an underlying problem
- Improve medical-device risk management
Prepared by Advisera experts to help you get started with EU medical device incident reporting.
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