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Evaluation ViewAttendees 17

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies

Wednesday, October 4, 2023
4:45 PM – 5:45 PM EDT
Location/Room: 513F
Intermediate Level
IVDR implementation is rapidly evolving, however, one thing is clear: the performance of a CDx needs to be supported by clinical evidence, preferably derived from clinical studies. Before a CDx clinical performance study (CPS) can begin, the appropriate authorization or notification of EU member states needs to be executed. This session will discuss the current guidance available for PS authorization applications in the absence of EUDAMED, considering countries specific guidance on IVDR implementation, the complexities of multinational trials in the context of combined prospective trials (investigational medicinal product and device for performance study), and examples of gaps in regulatory guidance for implementation of IVDR.

Learning Objectives:

  • Understand the impact of combined trial (clinical trial and clinical performance study - CPS) design on the required IVDR regulatory path - authorization, notification, or country specific requirements.
  • Understand CPS submission dossier requirements, differences among countries, and the foreseeable challenges in obtaining authorization for combined trials.
  • Understand some of the gaps in available guidance to support a seamless application process across all EU member states.