Within the scope of the transition process from the 93/42 / EEC Medical Device Directive (MDD) to the 2017/745 Medical Device Regulation (MDR) for EVA Bag, Extension Line, Infusion Set products, which our company produces and offers to the market as Class IIa Medical Device, it has made Notified Body applications and provided the document extension. With the approval of the Competent Authority, the validity of our CE certificate continues and the relevant products are supplied to the market.
