Industry-First Reagent Certification Awarded to Beckman Coulter Life Sciences

Beckman Coulter Life Sciences is helping laboratories prepare for critical upgrades to comply with the new In Vitro Diagnostic Medical Devices Regulation (IVDR), and to clear up confusion for laboratories that will soon be governed by IVDR. 
 
To help laboratories make required upgrades, Beckman Coulter Life Sciences has achieved an industry first, offering more than 270 reagents for flow cytometry that are IVDR compliant and that are available immediately, three years before the EU deadline. To keep up with demand, the company has grown its network of certified manufacturing sites to include Marseille, France; County Clare, Ireland; Suzhou, China; Bangalore, India; and Miami, Fla. (United States). 
 
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), the standard 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 for 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 Beckman Coulter’s 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.” 
 
Beckman Coulter Life Sciences is one of the few reagent providers to also achieve listing status on the official European Database on Medical Devices (EUDAMED). 
 
Industry leaders agree that with just more than a year until the deadline for LDTs or “in-house IVDs,” the time to begin examining laboratory needs to ensure IVDR compliance is here. “Now is the time to start preparing the future of your non-CE marked assays that you’re currently running in the laboratory,” said Dr. Pieter Bogaert, Device Compliance senior expert at Qarad, a company specializing in Regulatory Affairs and Quality Systems for the IVD and MD industry. “The instructions for use of reagents will have a much more crucial role under the IVDR than they did under the IVDD.” 
 
IVDR-compliant single-color antibodies from Beckman Coulter Life Sciences 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. 

Product availability may vary across regions outside the European Union (EU), including China, India, Japan, and countries that accept the CE mark as the basis for their country-specific registration. 
 
A special resource guide has been created to assist labs at all stages of the IVDR marathon and includes eBooks, whitepapers, and frequently asked questions (FAQs), along with the opportunity to request a one-on-one consultation with an expert. 
 
Beckman Coulter Life Sciences is a worldwide resource for tools to help optimize research and manufacturing efficiency.