In Vitro Diagnostics
Geographic Coverage: Europe
Learning Level(s): Basic: Content is introductory in nature and requires no prior knowledge or experience to grasp concepts or related exercises., Intermediate: Content is appropriate for individuals who have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s)., Advanced: Content is intended for individuals who are well-versed in most/all concepts associated with the topic(s).
SessionType: Featured session
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 discuss the new requirements of the IVDR in relation to performance, safety and clinical evidences, an essential knowledge to allow attendees to develop strategies to prioritize their effort in the collection of supporting data for their products. Based on case studies, 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 existing products and ensure a smooth transition to the new regulation.