MagSi-DX Pathogen declared to meet IVDR
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.
Our MagSi-NA Pathogens kit is already used for RNA extraction in advance of PCR or LAMP analysis in major Covid-19 testing streets and laboratories in Europe.