From 1st May 2007 every medical device marketed in Italy must be notified to the Italian Ministry of Health databank. The only exception is for class I medical devices for which the manufacturer (and eventually its authorized representative) is not on the Italian territory.
Anyway, If you are the manufacturer and you want to register your MDs in the database of the Ministry of Health you should follow the indications below to ask for an account to the database ( this for the medical devices that belong to the category “ DEVICES OF CLASS AND ACTIVE IMPLANTABLE DEVICES, KITS AND ASSEMBLED DEVICES” ):
You need to download the company's delegation file, use the following link
Fill only the first two pages (The first 2 pages of delegation form need to be filled in letterheads from the Manufacturer. In the second page, the legal representative from the Manufacturer has to assign himself or another person from the Manufacturer, to be responsible for informatics communication. In the second page there is a table, the Manufacturer should check letter “A”)
Send the two pages with an identification document of the legal representative, to the address that you can find on first page.
From the Ministry of Health you will receive login and password to access the database.
You can delegate an Italian company to reduce the waiting time.
You can find the English version of the databank user manual:
Please note that there is no notification fee and if the device is a class I medical device and the manufacturer (and eventually its authorized representative) is not on the Italian territory, the notification to the Italian Competent Authority is desirable, to let us better monitor the market, but not compulsory.
Furthermore, devices already in the databank do not have to be notified a second time.
The search engine of our databank is available at the following link:
from which the full public dataset of the medical devices notified in our databank can be downloaded, clicking on the link "Scarica il dataset".