Healthcare1/9/2024 3:00 PM
The implementation of the new In Vitro Diagnostic Regulation (IVDR) within the European Union has introduced profound changes with far-reaching impacts on both manufacturers and users of in vitro diagnostic devices. Manufacturers operating within the EU are facing a vastly different regulatory landscape with the advent of the IVDR. This regulation places more stringent demands on manufacturers, necessitating a comprehensive overhaul of their operations.