ISO 20916:2019 is the first international standard dedicated to the design, conduct, documentation, and reporting of clinical performance studies for in vitro diagnostic (IVD) medical devices. It ensures that studies are conducted with scientific rigor, ethical responsibility, and regulatory alignment—especially under the EU IVDR (2017/746).
🔍 Why does it matter?
This standard sets a clear and structured framework for:
✔️ Good Clinical Practice (GCP) principles
✔️ Ethical conduct and informed consent
✔️ Robust, reliable clinical performance data
✔️ Defined roles for sponsors and investigators
✔️ Full traceability, data integrity, and regulatory readiness
Whether it’s for pre-market validation or post-market follow-up, the standard ensures IVD studies meet the highest expectations for participant safety, data transparency, and audit preparedness.
BiTrial has the experience in planning and conducting clinical performance studies that comply with 20916:2019 — supporting our partners across the CEE region with excellence in IVD clinical research. 🤝
Contact us to learn more about how we can support your clinical performance studies!