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    EUDAMED

    European Database on Medical Devices.

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

    Definition

    EUDAMED is the IT system established by EU MDR/IVDR for registering devices, economic operators, certificates, clinical investigations, vigilance, and market surveillance information.

    What this means in practice

    EUDAMED is being rolled out by module. Mandatory use of certain modules begins as each is declared functional.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    European Commission·1RAPS·1FDA·1
    1. 1
      EUDAMED
      Verified
      European Commissionec.europa.eu
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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