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    Electronic Medical Device Reporting

    FDA's mandatory electronic submission system for Medical Device Reports.

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

    Definition

    Since 2015, all manufacturer and importer MDRs must be submitted electronically via the FDA eMDR system using the FDA Form 3500A schema, either through the Electronic Submission Gateway or the Web Trader interface.

    What this means in practice

    Direct system-to-system integration with complaint-handling systems is now standard for high-volume reporters.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·1European Commission·1MDCG·1
    1. 1
      FDA eMDR
      Bot-blocked
      FDAfda.gov
    2. 2
      EUDAMED Public Site
      Verified
      European Commissionec.europa.eu
    3. 3
      MDCG Vigilance Guidance
      Verified
      MDCGhealth.ec.europa.eu

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