Commercial readiness in light of In Vitro Diagnostic Regulation (IVDR)

There is no question that the new 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 organization is, as defined by IVDR? Understanding and analyzing 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 previous 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 research use only vs general lab use in relation to IVDs.

Join three leaders in the fields of in vitro diagnostics as they cover:

• New responsibilities of economic operators, who are defined as a manufacturer, distributor, authorized representative, importer, or 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

Who should attend?

• Stakeholders in molecular diagnostics, IVD manufacturers and clinical labs globally, including decision makers in R&D, quality staff and operational staff.