Beckman Coulter Life Sciences (Indianapolis) has received an EU Quality Management System Certificate under the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) for more than 200 flow cytometry reagents manufactured at its Marseille, France facility.
In May 2022, IVDR 2017/746 will replace the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been in place since 1993.
Beckman Coulter Life Sciences notes that it has prepared for IVDR 2022 for more than four years, enlisting multiple teams in the effort.
“We have worked to ensure our existing CE-IVD portfolio, including reagents, kits, software and instruments remain compliant to meet the new regulation,” said Dr. Mario Koksch, vice president and general manager of the company’s flow cytometry business unit. “As IVDR compliance also requires significant effort from individual laboratories,…