Companion-Diagnostic-(CDx)-Products: EU-Regulations

CDx products are specifically intended to identify patients who are targeted for therapy and who have a previously identified disease or genetic risk. A new classification system for companion diagnostics is introduced by the In Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) along with the requirement to submit to conformity evaluation by a designated authority. The Regulation is in effect from May 26, 2022, after a five-year transition period.

This Whitepaper is focused on:

  • Objectives of Companion Diagnostic (CDx) Products EU Regulations
  • Background of the Regulatory Pathway for Approval
  • Proposed solutions
  • Overview of EU – Regulation IVDR 2017/746