The new registration and communication modalities of the data regarding medical devices are provided by the Ministerial Decree of the 20TH  of February 2007. The notification of the medical devices is effected through the web and can be carried out by the manufacturers, by the manufacturer's authorized representative, or by other subjects  delegated by the manufacturer.

Foreign country operators gain access to the system through the ministerial's web portal (www.ministerosalute.it)  whilst the Italian operators through the web portal of the enterprises  (www.impresa.gov.it).  For the notification the Italian operators use a smart card which allows the identification and the digital signature without any further authorizations by the Ministry.

Only after receiving confirm of the data inserted into the database, the device results being notified to the Ministry of Health, which can  view and control the information on its computer terminals;  if the information received is correct the system provides to "publish" them in the list of the devices.

The manufacturer or its authorized representative, will in the future communicate with the same modalities any eventual variations to the initial notification. Medical Devices which will be bought by the NHS besides being registered in the databank they must also be registered  in the "Listing".  This further registration can be carried out together with the notification as a single operation.

The Listing is  exclusively consulted electronically  by the manufacturer or by a delegated person through the Ministry of  Health's website . At the end of the registration a listing number is assigned to the device which will univocally identify it in all the market activities with the NHS.

The listing has the purpose to allow an economic evaluation by the NHS and to determine the price reference of the devices. These evaluations are facilitated by the CND classification  (National Classification of MD) which gathers the devices in homogenous classes easily comparable.

Di Renzo Regulatory Affairs carries out, by proxy from the manufacturer, the registration in the data bank and in the listing according to the modalities expected by the Decree of the Ministry of Health of the 20th of February 2007.