The In Vitro Diagnostics Regulation (IVDR) is the new regulatory framework which will affect all in vitro diagnostic medical devices on the European market. The IVDR (Regulation (EU) 2017/746) replaces the EU Directive on in vitro diagnostic devices (IVDD 98/79/EC) and will apply from 26 May 2022 onward.
Our product MagSi-DX Pathogen (to be used for the isolation and purification of viral RNA for subsequent in-vitro diagnostic purposes) has been declared to meet the IVDR requirements and, subsequently, has been registered at the official government body.
We will continue marketing MagSi-DX Pathogen and other clinical diagnostic extraction products, compliant with the new regulations.
We congratulate everyone in and outside of magtivio who made this IVDR compliance possible.