We are IVDR

IVDR Conformity Assessment

We are glad to announce a huge success – the EXBIO IVD medical devices KOMBITEST TBNK 6-color (Cat. No. ED7733) and DryFlowEx TBNK 6-color (Cat. No. ED7736) are IVDR compliant!

These our devices, intended for detection and enumeration of lymphocyte population and subsets in human whole blood by flow cytometry, comply after their conformity assessment with a participation of the Notified Body with the essential quality management system requirements according to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices as ammended (IVDR).

As a result the EU Declaration of Conformity (DoC) had been drawned up and signed on 01.07.2024. This is a really eminant milestone. We are delighted with this success. Many thanks and congratulations go to all our colleagues who were responsible for it.

We're now continuing on our path to all EXBIO CE IVD products will be in a compliance with the IVDR.

To meet these requirements and prove this in evidence on products is necessarily for their possibility of sale in the EU.

Now we've just submitted the second round of the IVDR conformity assessment for our further four CE IVD products - ED7750 DryFlowEx PNH High-Sensitivity Assay Kit, ED7734 KOMBITEST T Cell 4-color, ED7080 CD34 QuantiFlowEx Kit, ED7043 BasoFlowEx Kit, we expect to be added to our EU Quality Management System Certificate till the end of 2024.

The third round of the IVDR conformity assessment for remaining products is planned to a summer 2025.

This attainment is great. EXBIO is still one of the first in the world to already enjoy the IVDR certificate in the field of Flow Cytometry.

For more details, please visit our web site www.exbio.cz