IVD Regulation is evolving, with direct impacts on CDx development. The purpose of this presentation will be to explore special provisions for CDx in the new IVDR, outline when industry need to start implementing these special provisions, determine how Notified Bodies are dealing with the new IVDR and impact on CDx, discuss what the role of the EMA will be for CDx, and review what the new IVDR will mean for CDx labelling and laboratory developed tests.

Sylvie Le Glédic is the Director, Medical Devices & IVD at VCLS. She is actively involved in the evolution of the EU IVD and MD regulations, and closely follows the new rules for regulatory approval of Companion Diagnostics (CDx), both in EU and US.

View Profile

Download the full presentation now