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IVDR Classification Rules

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For the last episode of this webinar series, we discuss the classification rules introduced by the European In Vitro Regulation EU 2017/746.

 

The new European IVD regulation is replacing the list-based classification system of the European IVD Directive by a rule-based classification. This system, driven by the intended use of a device, is designed to be future-proof and is the base to determine the applicable conformity assessment route and level of information required to demonstrate conformity and prepare post-market activities.

 

In this webinar, we will present the various rules, provide examples of devices and the rule interpretation. This will be the opportunity for manufacturer to better understand the meaning of each rules and better prepare the transition of their portfolio to the European IVD Regulation.


About the speaker

Dr. Julien SenacDr. Julien Senac

Global Director of IVD Focus Team, TÜV SÜD

Dr. Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD. Before this, he has many years of experience with a certification body, where he participated in the preparation of IVDR designation and performed Design Dossier assessment of in vitro diagnostic devices. Dr. Senac has a Ph.D. in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr. Senac has also participated in the development of multiple biotech start-up companies in oncology, gene therapy, and AIDs technologies.

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