A person in a white shirt holds a pen and reviews printed documents on a desk, possibly referencing ISO 20916 standards while making notes on text, charts, and colorful graphics.

What is ISO 20916?

ISO 20916 is an international standard for good study practice specifically for clinical performance studies using in vitro diagnostic medical devices (IVDs). It is referenced in recital (66) of the IVDR corrigendum of 03/05/2019:

“The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 20916 on clinical performance studies using specimens from human subjects (…).”

The standard specifies how clinical performance studies are to be conducted under the IVDR and sets out requirements for key elements of study organisation and conduct, including:

  • Ethical considerations and informed consent of study participants
  • Study planning and roles/responsibilities (sponsor, investigator)
  • Clinical performance study design
  • Clinical performance study plan/protocol (CPSP), including endpoints
  • Investigator’s brochure
  • Study documentation and data integrity (e.g., CRF/eCRF, audit trail)
  • Management of adverse events
  • Selection and qualification of study sites
  • Monitoring plan, quality management, and audits
  • Study initiation
  • Study conduct
  • Study close-out, data analysis, and reporting

ISO 20916 Put Into Practice – A Brief Summary

To ensure robust results, define responsibilities and protect the subjects providing specimens, ISO 20916 specifies general requirements, such as:

  • Endpoints and population: clearly defined performance characteristics (e.g., sensitivity, specificity), and the IVD’s target population
  • Comparator: an appropriate reference method with justification
  • Specimen management: pre-analytical conditions, storage and retention of samples, and traceability
  • Statistics: sample size and analysis plan
  • Quality and safety: risk-based monitoring, deviations; reporting of adverse events and device deficiencies
  • Electronic systems, documents, and regulatory authorities: CPSP, Investigator’s Brochure, and CRF/eCRF; notification/authorisation to national authorities under the IVDR

Want to learn more about applying ISO 20916 and GCP in performance studies? Get in touch.

Contact us now

Dr. Nina Miljanovic Jovanovic, Senior Study Manager

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CPSP: Clinical Performance Study Plan/Protocol

CRF: Case Report Form

eCRF: electronic Case Report Form

EUDAMED: European Database on Medical Devices

GCP: Good Clinical Practice

ISO: International Organization for Standardisation

IVDs: In vitro diagnostics

IVDR: In Vitro Diagnostic Regulation

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