The new European In Vitro Diagnostic Regulation (EU IVDR) is coming May 26, 2022 and if you want to continue to do business in Europe, now is the time to prepare your company for the various and complex new mandates ranging from procedures, evidence development, documentation, organizational structures, data management, reporting and reassessment of legacy portfolios.
This session is focused on Supply Chain Management – Economic Operators, UDI and Labeling. The new EU IVDR requires substantial, costly and challenging changes in supply chain management regarding relationship and performance. This will affect suppliers, subcontractors, distributors and other economic operators and due to the detailed complexity of the mandates, companies must plan quickly and carefully to be successful.
Topics covered are:
- Why the new emphasis on supply chain?
- Mapping the supply chain requirements to IVDR regulations
- Definitions, responsibilities and contractual agreements of economic operators
- Assessment of systems for evaluating, monitoring and documenting supplier performance and providing greater traceability and transparency
- Compliance, quality, verification and reporting issues
- New labeling and IFU requirements
- Traceability, UDI and reporting requirements