EU IVDR - Process, Data, Reporting & Planning
The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels.
Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market.
Recorded March 30, 2021: EU IVDR Introduction
Recorded April 6, 2021: Quality Processes and Documentation
Recorded April 13, 2021: Clinical Evidence & Surveillance
Recorded April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling
Recorded April 27, 2021: Strategy and Planning