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    ISO/TR 24971

    Guidance on the application of ISO 14971 to medical devices.

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

    Definition

    ISO/TR 24971:2020 provides guidance on developing, implementing, and maintaining a risk management system per ISO 14971, including hazard identification, risk control, residual risk evaluation, and post-production information.
    What the regulation says
    ISO/TR 24971:2020 offers supplementary guidance to ISO 14971:2019, providing practical methods and examples for establishing, documenting, and maintaining a risk management system. While not a normative standard itself, regulators and notified bodies expect manufacturers to consider its recommendations for demonstrating conformity to risk management requirements, such as those in EU MDR Annex I Chapter I Section 3.

    What this means in practice

    TR 24971 is the de facto playbook for executing ISO 14971 in practice and is frequently referenced by auditors and notified bodies.

    Examples

    • A MedTech manufacturer uses the guidance in ISO/TR 24971 section 6.2, 'Risk analysis techniques,' to select appropriate methodologies for identifying hazards and estimating risks for a new surgical robot.
    • During a notified body audit for CE marking, a manufacturer references specific examples from ISO/TR 24971 regarding risk control measures to justify their approach to mitigating software cyber risks in their diagnostic imaging system.
    • A quality manager consults ISO/TR 24971 Annex C, 'Guidance on safety-related information,' to improve their post-market surveillance process for collecting and analyzing field data relevant to risk management.
    Common pitfalls
    • •A common pitfall is treating ISO/TR 24971 as a standalone requirement rather than as guidance for implementing ISO 14971.
    • •Manufacturers sometimes fail to periodically review and update their risk management processes based on the evolving recommendations in ISO/TR 24971.
    • •Overlooking the interconnectedness between risk management activities and other quality system elements, such as design control or post-market surveillance, is a frequent mistake.

    Frequently asked questions

    No, ISO/TR 24971 is a technical report providing guidance, not a normative standard with auditable requirements. Its purpose is to aid in the effective application of ISO 14971:2019.

    Cross-references

    See also

    Closely related context worth reading.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    ISO·2FDA·1
    1. 1
      ISO/TR 24971:2020
      Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org

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