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    Notified Body

    EU-designated organization that assesses conformity of medical devices.

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

    Definition

    A Notified Body is an organization designated by an EU Member State to assess the conformity of certain products before they are placed on the market under EU MDR or IVDR.

    What this means in practice

    Notified Body capacity has been a major bottleneck under MDR/IVDR, influencing transition timelines and product availability across Europe.

    Cross-references

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    European Commission·1RAPS·1FDA·1
    1. 1
      NANDO Database
      Needs review
      European Commissionsingle-market-economy.ec.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.