IVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements
Author: Suzanne Broussard, PhD | June 8, 2021 In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes […]
EUDAMED3 Update: Two More Eudamed Modules Will Be Available Later This Year & Guidance on Alternatives Until the Remaining Three Modules are Released and the Database is Fully Functional
Author: Suzanne Broussard, PhD | May 3, 2021 By the end of the year, the first three modules will be accessible on the European medical device database, Eudamed3: Actor Registration, Unique Device Identifiers (UDI)/Device Registration, and Notified Bodies Certificates. […]
