Industry-first IVDR-Compliant Reagents for Flow Cytometry
Apr 19 2023
To help laboratories prepare for the upcoming In Vitro Diagnostic Medical Devices Regulation (IVDR) and to clear up any confusion, Beckman Coulter Life Sciences has achieved an industry-first by offering more than 270 reagents for flow cytometry that are IVDR compliant and available immediately. This is three years ahead of the May 2024 deadline set by the European Union. The company has also expanded its network of certified manufacturing sites to include locations in France, Ireland, China, India, and the United States to meet demand.
The IVDR is designed to ensure that in vitro diagnostic products achieve the highest levels of safety and efficiency, replacing the In Vitro Diagnostics Directive (98/79/EC) (IVDD) that has been in effect since 1993. The change will heavily impact labs using Laboratory-Developed Tests (LDTs) or ‘in-house IVDs’, which are the majority of clinical flow cytometry tests. With the May 2024 deadline approaching, Beckman Coulter Life Sciences is providing a resource guide that includes eBooks, whitepapers, FAQs, and the opportunity to request a consultation with an expert.
Dr Andreas Böehmler, Director of Clinical Solutions Product Management for the Global Flow Cytometry Business Unit, emphasised that making the necessary changes to become IVDR compliant can take several months or more to successfully implement, so it is critical to start the process now to avoid potential and costly laboratory shutdowns.
Beckman Coulter Life Sciences is one of the few reagent providers to achieve listing status on the official European Database on Medical Devices (EUDAMED), with its IVDR portfolio searchable under its listed manufacturing site in Marseille, Immunotech SAS.
As the deadline for LDTs or ‘in-house IVDs’ approaches, industry leaders agree that now is the time to begin examining laboratory needs to ensure IVDR compliance.
Beckman Coulter Life Sciences' IVDR-compliant single-colour antibodies are intended to be used in conjunction with other antibodies for multicolour panel design and can be used for diagnosis, monitoring, or prognosis of patients with haematological abnormalities, neoplasms, disorders, immunodeficiencies, or autoimmune disease. Product availability may vary across regions outside the EU, including China, India, Japan, and countries that accept the CE mark.
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