IVDR: What You Need to Know about Europe’s Changing IVD Market
The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies...
CE Mark Process for In Vitro Diagnostic (IVD) Devices
In order to commercialize in vitro diagnostic (IVD) devices in the European Union, a CE Mark certificate is needed. This certification verifies that...