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.
Listen to our expert, Terrance Thiel, in the latest PharmaLex podcast to learn more.