Getting Ready for the IVDR

Episode 5,   Mar 11, 2022, 10:14 AM

IVDR Brings Huge Change to Manufacturers Distributing Products in Europe
The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where approximately 80% of products were self-declared to the IVD Directive.
Listen to our expert, Terrance Thiel, in the latest PharmaLex podcast to learn more.