IVD and Laboratories
ISO 20916: Clinical Performance Studies for IVD Medical Devices
ISO 20916 sets out good study practice for clinical performance studies of in vitro diagnostic medical devices that use specimens from human subjects. It covers how studies are planned, conducted, recorded and reported, so the results are credible and the rights and safety of the people providing specimens are protected.
At a Glance
- Standard
- ISO 20916
- Subject
- Clinical Performance Studies for IVD Medical Devices
- Group
- IVD and Laboratories
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard defines responsibilities for the sponsor and the principal investigator, and the documentation a study needs: a clinical performance study plan, ethics review where required, informed consent or a justified exemption, investigator qualifications, site agreements and a final study report. It covers studies that involve specimen collection from subjects as well as studies using leftover specimens, with expectations that vary with study design and risk to subjects.
Specimen handling is central. Collection, labeling, storage, transport, chain of custody and blinding of results all affect data integrity. Monitoring, deviation management and data management are there to show that the data in the final report is the data that was generated.
IVD makers use it to generate clinical performance evidence for submissions and for performance evaluation under the EU IVDR. It plays a role for IVDs similar to the one ISO 14155 plays for clinical investigations of other medical devices.
Who It Applies To
- IVD manufacturers sponsoring clinical performance studies
- Clinical laboratories and sites acting as investigators
- Contract research organizations running IVD studies
- Studies using leftover or banked specimens as well as prospective collection
What Auditors Check
Study Plan and Amendments
An approved clinical performance study plan with controlled amendments and the rationale for each.
Ethics and Consent
Ethics committee decisions and informed consent records, or a documented basis for exemption.
Specimen Chain of Custody
Traceable collection, storage, transport and disposition of specimens, with conditions recorded.
Blinding and Data Integrity
Controls that keep reference results and device results independent, and audit trails on study data.
Monitoring and Deviations
Monitoring reports, protocol deviations and an assessment of each deviation's impact on the data.
Final Report Consistency
A study report whose numbers reconcile to the raw data and whose conclusions match the claims in the instructions for use.
Related Services
BIMO (Clinical) Inspection Readiness
Readiness for FDA bioresearch monitoring inspections of device clinical studies: sponsors, CROs and sites.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
Industry Guides That Reference ISO 20916
ISO 20916
Check Your Quality System Against ISO 20916
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