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Beckman Coulter Life Sciences wins IVDR for flow cytometry reagents

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Beckman Coulter

Image courtesy of Beckman Coulter

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, we will continue to dedicate resources to help ensure our customers cross the IVDR finish line and reap the benefits.”

The company has also posed an IVDR resource guide, including eBooks, whitepapers and FAQs at the following URL: https://www.beckman.com/resources/industry-standards/ivdr.

The company anticipates receiving additional certifications in 2022.

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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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