Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process.
Local legislations, such as this one, are growing rapidly in Europe and strengthen the need for a professional European Authorized Representative present at all times.
As a non-EU manufacturer of medical devices, the manufacturer's legal representative must appoint a "responsible individual person or company" to register their product with the Italian database.
The official form needed is available here: [1] This "responsible individual person or company" will communicate with the Italian Ministry of Health on the manufacturer’s behalf.
Third party commercial entities, like distributors, should not register products for several reasons, a few of which are: The manufacturer should register their products through their Italian distributor who is not only familiar with the language and local regulations but also has responsibility if he is the "c) other individual responsible for trading medical devices as under article 13, paragraph 2 of legislative decree no.