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    Medical Device Coordination Group Guidance

    Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements.

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

    Definition

    The MDCG, composed of competent authority representatives, issues numbered guidance documents (MDCG 2019-x, MDCG 2021-x, etc.) covering classification, clinical evaluation, vigilance, software, AI, and many other MDR/IVDR topics.

    What this means in practice

    MDCG documents are not legally binding but set the de-facto interpretive baseline for Notified Bodies and competent authorities; ignoring them is risky.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    European Commission·1RAPS·1FDA·1
    1. 1
      MDCG Guidance
      Verified
      European Commissionhealth.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.