Clariance SAS obtains the CE marking of four new implantable medical devices extending the Idys® thoraco-lumbar cage offerings to include the internationally offered Idys®-ALIF sterile packed, Idys®-ALIF TiVac, Idys®-TLIF Tivac, and Idys®-TLIF 3DTi. The certification granted by GMED has opened the door to allow these four new technologies developed by Clariance to be offered in markets which require CE marking.
CE marking assures that a product complies with the essential requirements defined by the European directives. Only CE marked products are permitted to circulate freely throughout the territory of the European Union.
Willy Vivanz, CTO and Site Manager recalls, “Not only did we attain an evaluation of four new implantable medical devices to be placed on the market according to MDD 93/42 / EEC, but additionally our second Notified Body, GMED, authorized these CE markings and confirmed our request for exceptional renewal during a second audit on the table that will extend the validity of our certificates from February 2023 to May 2024. This success further confirms the competence and commitment of the team.”
Thierry Manceau, General Director, adds, “What other spine company can claim that they put four new technologies on the international market in less than half a year, only three months prior to the implementation of the new European regulation MDR 2017/745? Clariance certainly has the ambition to become the best spine company out there.”