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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
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...
The Great Container Bake Off
With peak fall and holiday seasons around the corner there appears to be little prospect of a return to normal container shipping rates this side of next year’s lunar holiday. Fortunately, spikes [Fig 1] of this magnitude are few and far between, and while problematic...
