MedTech Terms
    The authoritative reference
    All terms

    IMDRF

    International Medical Device Regulators Forum.

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

    Definition

    IMDRF is a voluntary group of medical device regulators that work together to harmonize medical device regulation globally, building on the foundation of the Global Harmonization Task Force (GHTF).

    What this means in practice

    Many widely adopted concepts - SaMD risk categorization, MDSAP, UDI principles - originated in IMDRF working groups.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    IMDRF·1FDA·1European Commission·1
    1. 1
      IMDRF
      Verified
      IMDRFimdrf.org
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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