Medical Devices (includes In Vitro Diagnostics)
Applied
Julien Senac, PhD
Director, IVD Global Focus Team
Connie Del Buono
Founder, Director Regulatory & Compliance
Synoptyx Inc.
With at least 80% of IVD products on the current European market will have to submit an application to notified bodies in order to obtain CE marking, and without any grand-fathering rule, crucial strategic decisions will have to be taken by manufacturers in order to maintain their devices on the market after 2022. This session will dig through the new requirements of the IVDR in relation to performance, safety and clinical evidences, to allow attendees to develop strategies to prioritize their effort in the collection of supporting data for their products. The attendees will be able to identify multiple and original methods to obtain, gather or consolidated current data (equivalence, new studies, past experience, etc…) to answer the requirements of the IVDR for new and existing products and ensure a smooth transition to the new regulation