Sysmex obtains first IVDR certification for gene amplification detection reagent

Sysmex Europe GmbH has announced that LYNOAMP CK19 E, part of OSNATM method using a molecular biological technique for cancer diagnostics, is the first Sysmex product to be certified by a notified body under the new European In Vitro Diagnostic Medical Devices Regulation (IVDR) on 4 June 2021.

IVDR demands greater clinical evidence and a more stringent review of technical documentation and supporting evidence. Manufacturers of in vitro diagnostic medical devices are obliged under IVDR to obtain a notified body certification of the technical documentation and quality management system for their devices.

Since IVDR enforcement in May 2017, Sysmex has been working tirelessly to rapidly respond to the new regulation and to promptly obtain the IVDR certification for its products. The efforts are recognized with this first major milestone when the company acquired IVDR certification in Europe from the notified body TÜV SÜD Product Service GmbH for LYNOAMP CK19 E as a risk class C in vitro diagnostic medical device.

“This is a significant achievement for Sysmex and confirms our position as front-runners in the IVD industry with our prompt response to the latest changes in the European regulatory landscape,” says Alain Baverel, President & CEO at Sysmex Europe.

“The level of scrutiny that a risk class C, IVD product such as LYNOAMP CK19 E is under is enormous. The biggest step is taken, and we have paved the way,” continues Samantha Giangregorio, Vice President Life Science at Sysmex Europe.

Going forward, Sysmex confirms its commitment and diligence in acquiring IVDR-mandated certification for required IVD products in the European market and continues to contribute to healthcare by providing high-quality, high-medical-value products to customers.

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