Biosynex: obtains CE markings under the new IVDR regulations

(CercleFinance.com) - Biosynex announces that it has obtained the first CE markings under the new IVDR regulation, which aims to reinforce the safety and efficacy of in vitro diagnostic devices.


These CE markings enable Biosynex to market Class B and C rapid and molecular biology tests for the detection of infectious agents, including sexually transmitted agents, as well as the first coagulation test developed by the AVALUN subsidiary (INR measurement).

These initial markings will facilitate obtaining CE IVDR certification for other similar products via a simplified procedure.

The other products in Biosynex's in vitro diagnostics catalog benefit from an extension period under the old European Directive (Directive 98/79/EC), which should last until 2027 depending on the product class.

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