Commercial readiness in light of IVDR
Speaker
Sue Spencer
Head of In Vitro Diagnostics & Principal Consultant, Qserve Group
Speaker
Erik Vollebregt
Founding partner, Axon Lawyers
Speaker
Dr. Julien Senac
Global Director – IVD Focus Team, TÜV SÜD
Topics covered
- New responsibilities of Economic Operators, who are defined as manufacturer, distributor, authorised representative, importer and any person referred to in Article 22(1) and 22(3). What is the impact of Brexit?
- What will the impact of IVDR be on your product portfolio – Research Use Only, IVD or General Lab use
- Confirming the product is an IVD and understanding whether your IVD classification will change under IVDR
Additional resources
View webinar slides
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IVDR in light of the COVID pandemic: the near future of in vitro diagnostic testing
Getting ready for IVDR