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.”
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). Customers can view the entire IVDR portfolio by searching for our listed manufacturing site in Marseille, Immunotech SAS.
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. Please consult with a Beckman Coulter Life Sciences associate for up-to-the-minute specifications and certifications.
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. Simply visit https://becls.co/3KjJgBa