Webinar - Commercializing Diagnostic Assays in Europe - What North American manufacturers need to know about IVDR CE marking

Understand the regulatory expectations, avoid common pitfalls, and prepare for a successful IVDR submission.

Europe represents one of the world's largest markets for in vitro diagnostics, but bringing diagnostic assays developed under CLIA, CAP or ISO 15189 to the EU requires more than simply adapting existing documentation.

Whether you're a diagnostic manufacturer or clinical laboratory developing Laboratory Developed Tests (LDTs), understanding the additional evidence, performance evaluation and regulatory requirements under the EU In Vitro Diagnostic Regulation (IVDR EU Regulation 2017/746) is critical to achieving CE marking efficiently.

Join experts from a European designated Notified Body for a practical webinar exploring what it takes to successful commercialize diagnostic assays in Europe. We'll explain the key differences between North American and European regulatory expectations, share common observations from IVDR conformity assessments, and provide practical guidance to help you prepare for certification with confidence.

Webinar details

  • Date: Wednesday, 9 September 2026
  • Time: 9:00 -10:00 AM (PDT)
  • Speakers:
    • Kenneth Fuh, IVDR Technical Manager and Auditor, DNV
    • Elizabeth Bernal, Senior Auditor, DNV
  • In this webinar you'll learn:
    • The key differences between CLIA, CAP and IVDR requirements.
    • When an LDT requires IVDR CE marking for the European market.
    • The evidence and documentation needed to support conformity assessment.
    • Common issues identified during Notified Body assessments, and how to avoid them.
    • Practical steps to prepare your organization for a successful IVDR submission.

Whether you're exploring European market entry or actively preparing for IVDR certification, this session will provide practical insights to help you navigate the process more effectively.