Background
According to Italy’s Decree of Feb. 20, 2007, all classes of medical devices introduced in Italy after May 1, 2007 must be registered in the Italian Ministry of Health Database. It has been confirmed by the Italian Ministry of Health that manufacturers of Class I Medical Devices with an EC Rep established outside of Italy are not obligated to complete such registration.
CRITICAL Update
While this may seem to be an improvement to the current system for Class I manufacturers, it is not necessarily in their best interest. If a manufacturer decides not to register its Class I device, the device is only authorized to be sold in the private sector, thus drastically reducing market potential and sales. With Class I registration, devices may be sold to both the public and private sectors.
– The Ministry of Health Data bank is used to generate a complete list of devices (called a “Repertorio”) that are sold to the Italian National Health Service, the “Servizio Sani¬tario Nazionale” (SSN).
– The registration can only be done with granted access to the Italian Database and with the required “smart card” for the actual registration (the entity must possess a “smart card,” which allows a user to digitally authenticate the data that has been entered into the database).
Please Remember:
Any regulatory registration is to be completed by your appointed Authorized Representative in Europe.
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