In-Vitro Diagnostics

The revision of the EU In Vitro Diagnostics Directive presents an opportunity for strengthening the current approval system for IVDs for the sake of patient safety, competitiveness and innovation. To ensure that the final outcome of the ongoing discussion is a well-performing approval system, several points specific to IVDs should be considered carefully. 

IVDs, especially companion diagnostics, play an essential role in Personalised Medicine and the patient-healthcare pathway. As non-invasive tests used for diagnosis, screening, assessing predisposition and monitoring, IVDs do not treat patients; instead, they rely on biological samples, including blood, urine or tissue, to provide a specific set of data regarding and individual's health status. 

There are certain intrinsic characteristics of IVDs that distinguish them from medical devices and pharmaceutical and it is important that the pending regulation continue to reflect this differences between IVDs and other medical technology. 

EAMP identified 7 key areas: 

  • Companion Diagnostic Definition 
  • Conformity assessment for companion diagnostics
  • Clinical evidence
  • In-house exemption for companion diagnostics
  • Marketed IVDs and new clinical evidence 
  • Gene sequencing and companion diagnostics
  • Transition period

For more information on the activities of this initiative, please contact Denis Horgan, Executive Director