Gradientech releases IVDR-compliant QuickMIC instrument and sample preparation kit
The diagnostics company Gradientech today announces that instrument and sample preparation kit as part of the previously CE-IVD marked QuickMIC® system, have been registered as IVDR Class A in compliance with the new European IVD regulation.The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 replaced the previous IVD Directive in the European Union as of 26 May 2022 to ensure continued safety and performance of in vitro diagnostic medical devices on the European market.
The IVDR-registration of the Class A products part of the QuickMIC system implicates that the diagnostic system now