COMPANION DIAGNOSTICS (CDx) - NAVIGATING THE REGULATORY CHALLENGES

The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorisation of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe. These processes are proving challenging and, in the absence of detailed guidance, often result in roadblocks and delays to development of CDx. EU Competent Authority, Notified Body and Regulatory Consultant CDx experts will share their experience at this seminar, t