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.
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