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, Director Medical Devices & IVD
Sylvie Le Glédic is in charge of the design and implementation of global regulatory strategies for the development and registration of in vitro diagnostics medical devices (IVDs). Sylvie helps IVD manufacturers in the creation of CE mark technical files and US regulatory dossiers for FDA approval, advising on the required Quality Management System. She assists pharmaceutical companies developing Companion Diagnostics (CDx) in the drug/CDx co-development and facilitates liaison between both pharmaceutical and diagnostic developers.