Beckman Coulter Life Sciences has received a EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for more than 200 flow cytometry reagents developed and manufactured at their Marseille, France facility.
The new European In Vitro Diagnostic Regulation 2017/746 (IVDR) is currently set to take effect in May 2022 and replaces the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been followed since 1993. The change can impact European clinical flow cytometry labs, including those using laboratory-developed tests (LDTs).
“IVDR 2022 is a marathon – not a sprint – for us as well as clinical laboratories,” says Mario Koksch, PhD, MD, vice president and general manager of the company’s Flow Cytometry Business Unit. “For more than four years, Beckman Coulter Life Sciences has dedicated multiple teams to prepare for this achievement, which further showcases our unique and market-leading position in clinical flow cytometry. We have worked to ensure our existing CE-IVD portfolio, including reagents, kits, software and instruments remain compliant to meet the new regulation. As IVDR compliance also requires significant effort from individual laboratories, we will continue to dedicate resources to help ensure our customers cross the IVDR finish line and reap the benefits.”
Additional certifications are expected in the near future. 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 established to assist labs at all stages of the IVDR marathon and includes eBooks, whitepapers, and FAQs, along with the opportunity to request a one-on-one session with an expert.
Featured image: Beckman Coulter Life Sciences received a EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation for more than 200 flow cytometry reagents. Photo: Beckman Coulter