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Gradientech's QuickMIC System Gains IVDR Compliance

NEW YORK – Gradientech said on Monday that its QuickMIC instrument and sample preparation kit are both compliant with Europe's new In Vitro Diagnostic Regulation. The system can be used to determine the best antibiotic treatment for sepsis patients based on phenotype susceptibility testing.

Uppsala, Sweden-based Gradientech had already obtained a CE-IVD mark for the QuickMIC system earlier this year under the outgoing IVD Directive. The IVDR began to apply in May, and the company subsequently ensured its compliance with the new regulation as a Class A device. Under the IVDR, manufacturers can still obtain a CE-IVD mark for Class A devices, such as laboratory equipment and sample preparation kits, via a self-certification process.

Gradientech CEO Sara Thorslund said in a statement that the firm has "worked in a very structured way with quality management and regulatory compliance," and that the certification of the QuickMIC system under the IVDR "shows that focus and commitment pays off."

Gradientech obtained a CE-IVD mark for a Gram-negative panel that runs on the QuickMIC system in May, before the IVDR began to apply. The EU earlier this year decided that tests holding certificates prior to the date of application would have several years to gain compliance with the IVDR. As such, most molecular tests holding CE-IVD marks prior to May 26 may be used clinically until May 2026.