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    Manufacturer Incident Report

    Standardized EU vigilance report submitted to competent authorities via EUDAMED.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    MIRs use a harmonized template (initial, follow-up, final) capturing serious incident details, root cause, CAPA, and FSCA linkage. EUDAMED is the central submission channel.

    What this means in practice

    MIRs replaced legacy national-format reports; alignment with FDA MDR data fields helps run a single global vigilance database.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    MDCG·1European Commission·1FDA·1
    1. 1
      MDCG 2023-3
      Verified
      MDCGhealth.ec.europa.eu
    2. 2
      EUDAMED Public Site
      Verified
      European Commissionec.europa.eu
    3. 3
      FDA MAUDE Database
      Verified
      FDAaccessdata.fda.gov

    Inline markers like [1] jump to the matching reference above.