Beckman Coulter Life Sciences achieves industry-first reagent certification to help prepare labs for IVDR

Beckman Coulter Life Sciences is helping laboratories to prepare for critical upgrades to comply with the new In Vitro Diagnostic Medical Devices Regulation (IVDR) by offering more than 270 reagents for flow cytometry that are IVDR compliant and available immediately. IVDR-compliant single-color antibodies from Beckman are platform-independent and intended to be used in conjunction with other antibodies for multicolor panel design. Conjugated IVDR-compliant antibodies can be used for diagnosis, monitoring, or prognosis of patients with hematological abnormalities, neoplasms, disorders, immunodeficiencies, or autoimmune disease.

IVDR is designed to ensure that IVD products achieve the highest levels of safety and efficiency. It replaces the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been followed since 1993. This change heavily impacts labs using laboratory-developed Tests (LDTs) or in-house 'IVDs', which constitute a majority of clinical flow cytometry tests. The next important deadline with regards to IVDR and LDTs is May 2024.

“Workflow changes to support IVDR can take several months if not more than a year to fully and successfully implement, so now is the critical time to clear through the confusion and make necessary changes to be IVDR compliant,” said Dr. Andreas Böehmler, Director of Clinical Solutions Product Management for the Global Flow Cytometry Business Unit. “We know this is a marathon and not a sprint, which is why we started this process in 2018 and continue to lead the way to help guide customers to take the required steps to avoid a potential and costly laboratory shutdown. While this impacts countries including the European Union, we know the world is watching, with IVDR to potentially become a global standard.”

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