bioMérieux receives CE Mark certification for IVD products maketed in the European Union08 January, 2004
Marcy l'Etoile, France - January 8th, 2004. bioMérieux has received CE Mark certifications for all of its in vitro diagnostic (IVD) products currently marketed in the European Union (EU). In compliance with the requirements of the 98/79/EC directive for CE Marking, which became applicable on December 7th, 2003, these certifications enable bioMérieux to continue to sell its products within the European Union after this date.
The objective of the new European regulation is to harmonize the in vitro diagnostics market throughout Europe, by standardizing product registration procedures for IVD manufacturers. Under the 1998 In Vitro Diagnostic Directive (IVDD), companies disposed of a 5-year transition period, from 7/12/1998 to 7/12/2003, to comply with the 98/79/EC directive.
The end purpose of the IVD/CE directive is to reinforce patient safety, and the CE Mark on bioMérieux products reflects the company’s constant commitment to provide “state-of-the-art” products to both customers and patients.
“CE Marking has been a critical project for bioMérieux” says Stéphane Guerbert, CE Marking project manager, France, “and, thanks to our dedicated teams, we were on target for the objectives set for France six months before the December 7th deadline.”
Over 300 employees working at bioMérieux headquarters and in seven subsidiaries were involved in the project, producing over 6,000 documents and 4,000 translations. In France, more than 500 products were tested and certified to comply with the essential requirements of the relevant European health, safety and environmental protection legislations, which are a guarantee of reliability and security for the patient.
In addition to the French sites, four other bioMérieux productions sites producing around 300 products also marketed in Europe were required to implement the requirements of the directive, namely Boxtel (NL), Basingstoke (UK), Durham and Saint Louis (US).
The most visible changes due to CE Marking on the packaging of bioMérieux products relate to the standardization of product labels, and the production of labels and instructions in 10 different European languages.