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 fulfils the new regulatory requirements and transition provision for the European market. Following clinical performance evaluation, all devices constituting the QuickMIC system were CE-IVD marked earlier in 2022, indicating IVDD compliance.
“Gradientech has during our design and development phase worked in a very structured way with quality management and regulatory compliance, proven for example by our early ISO13485 certification already back in 2017. Our transition to the IVD regulation is well prepared and today’s registration of our Class A products shows that focus and commitment pays off”, comments Dr Sara Thorslund, co-founder and CEO of Gradientech.
The QuickMIC system is today the most rapid CE-IVD marked system for diagnosis of optimised antibiotic treatment of sepsis patients, based on phenotypic susceptibility testing. The QuickMIC system’s ultra-rapid and precise results enable patients with sepsis to quickly receive specific personalized guidance of the right antibiotics in the right dose. The modular design makes it flexible and allows hospitals to start on a small scale and then scale up as needed.
For more information please contact:
Sara Thorslund, PhD, CEO Gradientech
Tel: +46 736 29 35 80
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