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    ISO 14155

    Good clinical practice for clinical investigations of medical devices.

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

    Definition

    ISO 14155:2020 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.

    What this means in practice

    ISO 14155 is the device-specific counterpart to ICH-GCP and is referenced by EU MDR clinical investigation requirements.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Contains

    Sub-elements or required artefacts of this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1AAMI·1FDA·1
    1. 1
      ISO 14155:2020
      Verified
      ISOiso.org
    2. 2
      AAMI Standards
      Verified
      AAMIaami.org
    3. 3
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov

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