The certification is a procedure stating whether a product o process meets the applicable technical Regulations requirements . The CE marking product certification and the company quality system certification are two cases in point. In the specific case of product marking, this allows medical device manufacturers to place a specific marking on the device or on its packaging. On the other hand, the registration is a necessary procedure to obtain the authorization to sell Medical Devices in a certain country market. The certification is issued by a private entity, called Certification Body, while the registration is completed by the competent Authority of the country where the device is intended to be marketed. In Europe, for example, manufacturers can market Medical Devices once obtained the CE certification and the device registration with the competent Authority of the EU country where the manufacturer is established. While, in some non-EU countries, Medical Devices marketing only requires a registration with the competent Authority , and product marking, therefore a certification process, is needed only for some specific device types.