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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 the regulation says
    ISO 14155:2020 outlines the principles of good clinical practice (GCP) for medical device clinical investigations, ensuring the protection of human subjects, the scientific integrity of the investigation, and the reliability of study results. The EU MDR, specifically in Annex XV, refers to the principles of ISO 14155 for clinical investigations of devices.

    What this means in practice

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

    Examples

    • A MedTech company conducting a clinical investigation for a novel coronary stent needs to ensure all study procedures, from subject consent to data collection, are compliant with ISO 14155:2020.
    • Before initiating a multi-center clinical trial for a new diagnostic imaging device, the sponsor performs site audits to verify that each participating institution understands and can adhere to ISO 14155 requirements.
    • During a clinical investigation for a new orthopedic implant, a data monitoring committee operating under ISO 14155 principles reviews accumulating data to ensure subject safety and ethical conduct.
    Common pitfalls
    • •Failing to update clinical investigation procedures to align with the 2020 revision of ISO 14155 can lead to non-compliance.
    • •Applying pharmaceutical good clinical practice (GCP) guidelines directly to MedTech without considering the specific nuances of ISO 14155 can result in inefficient or inappropriate study designs.
    • •Neglecting the ethical considerations and subject protection requirements detailed in ISO 14155 can lead to regulatory enforcement actions and reputational damage.
    • •Not adequately training investigators and site staff on ISO 14155 principles can compromise data quality and subject safety.
    • •Incorrectly managing clinical investigation data according to ISO 14155 can invalidate study results for regulatory submissions.

    Frequently asked questions

    ISO 14155 is specifically tailored for medical devices, addressing their unique characteristics like device-specific risks and iterative design, while ICH-GCP is focused on pharmaceuticals. Both share core principles of ethical conduct and data integrity.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.