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Evaluation ViewAttendees 23

Devices (includes Medical Devices and In Vitro Diagnostics)

Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process

Thursday, October 5, 2023
4:45 PM – 5:45 PM EDT
Location/Room: 511E
Advanced Level
Description: Companion Diagnostics are still quite unknown in Europe even though they have been marketed for over 2 decades. IVD devices play a key role in assessing a patient`s state of disease condition, e.g. through the use of molecular profiling. And they are vital in generating information and data supporting use of the corresponding medicinal product. Notified Bodies are starting with certifying the first CDx devices in Europe. On top of the normal conformity assessment route, they have to include the consultation process with the competent authority or EMA which is new for both manufacturer and Notified Body. As part of this session we will have a look at the IVDR requirements specific for CDx and also the consultation process with the EMA. What are the lessons learned form the first SSPs and IFUs that have been assessed by the EMA?

Learning Objectives:

  • Understand the IVDR requirements specific for companion diagnostics.
  • Have more insight in the consultation process, EMA expectations and the timelines for this process
  • Have a better understanding from the Lessons learned of the first Companion Diagnostic devices that have been certified under the IVDR