Glossary · ISO and IEC standards for MedTech and pharma

ISO 20916

Also known as: ISO 20916:2019, EN ISO 20916, Good study practice for IVD clinical performance studies

ISO 20916 is the international standard of good study practice for clinical performance studies of in vitro diagnostic medical devices using specimens from human subjects. It sets requirements for planning, conducting, recording and reporting such studies to protect subjects and to ensure reliable performance data.

Standards
IVDR

In one sentence

ISO 20916:2019 sets good study practice for IVD clinical performance studies using human specimens, from study plan to final report.

Example

A manufacturer of a new sepsis biomarker assay runs a prospective clinical performance study in three hospitals under ISO 20916, with a clinical performance study plan, ethics approval, specimen accountability records and a final study report.

How it applies

Legal hook: Performance studies under Articles 57–77 IVDR must meet the regulation; ISO 20916 describes good study practice for the clinical performance part.
Study types: The standard covers interventional and non-interventional studies, including studies using leftover specimens, and scales requirements to the study's risk to subjects.
Core documents: Clinical performance study plan, investigator's brochure where required, informed consent or its justified waiver, case report forms, specimen handling records and the clinical performance study report.
Specimens: Traceability of specimens from collection to result and protection of subject data are central. Studies whose results may influence patient management carry additional requirements under the IVDR.
Technical documentation: The study report feeds the clinical performance evidence in the performance evaluation report and, for class C and D devices, the summary of safety and performance. Post-market studies are part of PMPF.

ISO 20916 vs. ISO 14155

Both are good-practice standards for studies in humans. ISO 14155 covers clinical investigations of medical devices, where the device acts on the subject. ISO 20916 covers clinical performance studies of IVDs, where the device examines specimens and the risk usually lies in sampling and in how results are used. An IVD study is planned with ISO 20916, not ISO 14155.