IVDR: What You Need to Know about Europe’s Changing IVD Market

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 selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this...
CE Mark Process for In Vitro Diagnostic (IVD) Devices

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 a device meets all regulatory requirements for IVDs, which will soon change under the new In Vitro Diagnostic...