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    ISO 20916

    International standard for Good Study Practice for clinical performance studies of IVDs using specimens from human subjects.

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

    Definition

    ISO 20916 is the IVD analogue to ISO 14155 - defining responsibilities, design, conduct, recording, and reporting of IVD clinical performance studies. EU IVDR Annex XIII references it as state of the art.

    What this means in practice

    Required reading for any IVD sponsor designing performance studies under IVDR; closes a long-standing gap in IVD-specific GCP guidance.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1FDA·1European Commission·1
    1. 1
      ISO 20916
      Verified
      ISOiso.org
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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