Agilent Technologies Inc. (NYSE: A) today announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A on May 26, 2022, in compliance with the new EU IVDR regulation.
This launch of IVDR-compliant Class A products ensures that labs in the EU who rely on Agilent IVDR instruments, kits, and reagents in their diagnostic workflows will continue to be able to use these products without disruption.
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is a new, harmonized regulatory framework established to ensure the present and future safety and performance of in vitro diagnostic (IVD) medical devices in the European Union market. The IVDR regulation replaces the previous IVDD directive, under which many Agilent products have been CE-IVD marked, indicating IVDD compliance. The launch represents a significant milestone for the Agilent organization, which faced substantial hurdles due to the COVID pandemic and related supply-chain challenges.
“Agilent shares the European Commission's vision of enhanced patient safety and transparency," said Jenipher Dalton, senior vice president of Global Quality and Regulatory Affairs at Agilent. "We remain committed to providing high-quality solutions for delivering the testing results that physicians and patients in the EU rely on. Our multi-disciplinary team really came together to make this a seamless transition, and this result is a testament to their dedication and professionalism.”
Agilent Class A IVDR-compliant products span the entire Agilent product portfolio, from qPCR and NGS preparation instruments to H&E stains, staining instruments, and conjugated secondary antibody reagents.