Eurobio Scientific becomes one of the first European companies to obtain IVDR1 CE marking of PCR tests - Seite 2

A critical know-how

CE marking and ISO certification in France according to the new, more stringent European standards represent a fundamental step in the Group's development, as they complement the similar certification that its subsidiary, GenDx, was the first to obtain in the Netherlands. This step confirms the Group's strong regulatory expertise, which is becoming a major asset for successfully developing and marketing new diagnostic tests, regardless of their origin in Europe.

With this now critical know-how, the Group demonstrates that it was able, in a very short time, to raise the quality requirements for its own products and successfully complete much more complex regulatory processes. Eurobio Scientific has thus built up a real high-value asset to ensure its future development.

« Getting of our new IVDR certification as well as the IVDR CE marking of the first 3 tests in our EurobioPlex line, constitute the culmination of a process of strengthening our quality and regulatory system which had already been underway for several years. I would like to thank here our employees without whom this major step for Eurobio Scientific would not have been possible, especially since this qualification is also a strong signal that we send to our partners and customers regarding the quality of our teams and our products. » says Cathie Marsais, Vice President of Operations at Eurobio Scientific.

Next financial meetings
Annual Shareholders’ meeting: June 13, 2023

About Eurobio Scientific Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 250 employees and four production units based in the Paris region, in Germany, in the Netherlands and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany, Antwerp Belgium and Utrecht in The Netherlands.