LGC BIOSEARCH Webinars

 

Commercial readiness in light of IVDR

Abstract

There is no question that the European In Vitro Diagnostic Regulation (IVDR) is complex and will have far-reaching implications. How ready is your business for the implementation of the new regulations? Do you know what the role of your organisation is as defined by IVDR? Understanding and analysing your product portfolio will highlight what you need to discuss with suppliers and subcontractors to ensure you develop a robust supply chain to maintain continuity.

Our last webinar, ‘Getting ready for IVDR’, helped equip you with information to draw up an action plan. In this webinar, our panel of experts will discuss the commercial considerations in more detail. We’ll examine the new responsibilities of Economic Operators, whether your product is an IVD according to IVDR classification and explore the Research Use Only vs General Lab use in relation to IVDs.

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

Speakers

Sue Spencer
Head of In Vitro Diagnostics & Principal Consultant, Qserve Group

Erik Vollebregt
Founding partner, Axon Lawyers

Dr. Julien Senac
Global Director – IVD Focus Team, TÜV SÜD