How does ISO 20916 relate to the EU IVDR?

ISO 20916 is a harmonized standard under the EU IVDR, meaning compliance with its provisions can provide a presumption of conformity with the relevant requirements of the regulation, specifically those related to clinical performance studies detailed in Annex XIII.

Who is responsible for ensuring compliance with ISO 20916?

The IVD manufacturer, as the sponsor of the clinical performance study, bears ultimate responsibility for ensuring compliance with ISO 20916, though responsibilities are often delegated to qualified individuals and organizations.

Does ISO 20916 apply to all types of IVD performance studies?

ISO 20916 applies to all types of clinical performance studies for IVDs, ranging from early feasibility studies to post-market performance follow-up studies, as appropriate to the stage of device development and regulatory requirements.

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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 September 19, 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. 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.

What the regulation says

ISO 20916:2019 specifies general requirements for the design, conduct, recording, and reporting of clinical performance studies for in vitro diagnostic medical devices (IVDs). This standard is harmonized under the EU IVDR, with Annex XIII, Part A, Section 1 referencing it as a recognized state of the art for performance studies. It provides a framework for ensuring the scientific validity and ethical conduct of IVD performance studies, aligning with principles found in other good clinical practice (GCP) standards.

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.

Examples

A manufacturer of a new immunoassay for a disease biomarker designs a clinical performance study following ISO 20916 to gather data on diagnostic sensitivity and specificity.
An IVD company developing a molecular diagnostic test for an infectious agent uses ISO 20916 as a guide to establish ethical considerations and informed consent processes for their study participants.
A regulatory body reviews a manufacturer's clinical performance study report for a novel IVD device, specifically assessing adherence to the data integrity and reporting requirements outlined in ISO 20916 clause 7.

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.

Frequently asked questions

The primary objective of ISO 20916 is to protect the rights, safety, and well-being of study participants while ensuring the scientific validity and reliability of clinical performance data for in vitro diagnostic (IVD) medical devices.

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EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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ISO 14155

Good clinical practice for clinical investigations of medical devices.

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

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

Remember this

Watch out: Confusing ISO 20916 requirements with those of ISO 14155, which applies to non-IVD medical devices.

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