The Notified Body authorizes the quality management System established and applied by the Company mentioned in the certificate. The requirements of Annex V, Article 3 of the EC directive 93/42/EEC, referred to as the Medical Device Directive (MDD), have been met. This approval is subject to periodic surveillance, defined in Annex V, Article 4 of the aforementioned EC-Directive, and can be used by the Company with the manufacturer's declaration of conformity.