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) 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 Regulation (IVDR...
5 Reasons To Outsource Your IVD Fulfilment And Distribution

5 Reasons To Outsource Your IVD Fulfilment And Distribution

The IVD sector is growing rapidly due to rising healthcare costs and consumer demand which has created a need for advanced tools that are fast, accurate, informative, affordable, and less invasive for clinical decision making. This shift within the healthcare industry...