The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022. This new regulation will introduce substantial changes in the sector as companies in the IVD industry...
Updated article: www.titansolutions.ie/ivdr-updated/ 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...
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...
