It is a decalration of product compliance with the essential safety requirements of one or more Community Directives applicable to the product itself. It certifies that the product has been subjected to conformity assessment procedures, which differ according to the product category and the applicable Directives. A CE marked product can therefore be marketed and used throughout the Community.
CE conformity, for DMs above class I, is issued by Notified Bodies accredited for the certification of specific types of medical devices and for specific marking procedures.
The manufacturer can contact any accredited Notified Body, in Italy or in another EU country, of his choice.