EU Quality Management System Certificate (IVDR)



EXBIO announces commitment to receive conformity assessment certificate for flow cytometry products under the new IVD Regulation (IVDR).

Approaching closer to the May 2022 deadline where all IVD products marketed in the EU must meet the new IVDR regulations, we are pleased to confirm to you our active steps to receive “EU Quality Management System Certificate (IVDR)” from the Notified body under the new IVDR on timely fashion.



CE certification will apply to the following product family groups for use in clinical flow cytometry laboratory:

a/ KOMBITEST multi-color TBNK assays (e.g. 6-color KOMBITEST CD3/CD4/CD8/CD16+CD56/CD19/CD45)

b/ SingleFlowEx single-color reagents (e.g. SingleFlowEx CD138 Pacific Orange™, SingleFlowEx CD45 Pacific Orange™, SingleFlowEx CD9 Pacific Blue™SingleFlowEx CD21 Pacific Blue™SingleFlowEx Kappa Chains Pacific Blue™)

c/ Flow cytometry kits (e.g. CD34 QuantiFlowEx Kit, FagoFlowEx kit, BasoFlowEx kit)



In addition, we will register our accessory sample preparation reagents (e.g. EXCELLYSE Easy, EXCELLYSE Xperm) as IVDR-compliant products.



About IVDR
Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices (IVDR) will fully replace the currently valid In-Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) on from 26 May 2022. Prior to the new IVDR coming into force, majority of CE IVD products were classified as self-declared devices and did not need to be reviewed by a notified body under the IVDD.

The new regulation redefines the system for classifying IVD products fundamentally.

EU Quality Management System Certificate (IVDR)” is mandatory for any manufacturer of in vitro diagnostic devices (IVDs) to issue declarations of conformity for their products and to get them certified in compliance with the new European regulation.

 

Jolana Vosahlova, Ph.D.
Director, Sales Department
vosahlova@exbio.cz