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. The 2019 edition covers study planning, ethics committee review, informed consent, conduct, monitoring, data management and reporting for studies using specimens from human subjects. It is widely used to support the performance study requirements in IVDR Articles 57 to 77.

Why it matters

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

Common pitfalls

•Confusing ISO 20916 requirements with those of ISO 14155, which applies to non-IVD medical devices.
•Failing to establish a comprehensive clinical performance study plan as required by ISO 20916 clause 5.2.
•Neglecting to appoint a qualified principal investigator and clearly define their responsibilities according to ISO 20916 clause 4.2.
•Not adequately documenting adverse events and their causality assessment during an IVD clinical performance study.
•Applying ISO 20916 retrospectively to studies initiated before its publication without a clear justification or transition plan.

Sources

ISO 20916 · ISO
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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