The Ministerial Decree of 20 February 2007, containing "New procedures for obligations under Article 13 of Legislative Decree No. 46 of 24 February 1997 and subsequent amendments, for the registration of active implantable devices and inclusion in the Medical Devices Directory", establishes that from 1 May 2007, registration in the medical devices database is mandatory, using new methods exclusively through the Businesses Web Portal. 

In fact, the Decree provides for the establishment of a new database of medical devices, also containing the Directory for devices for sale to the NHS, to be implemented in two stages. 

The initial phase, active since 1 May 2007, mandates registration in the database through the Businesses Portal desk solely for the marketing of a new product in Italy. Upon registration, a repertory number will be assigned concurrently, which is required from 1 August to sell these products to the NHS. 
The second phase, on the other hand, will also cover medical devices already marketed in Italy before the decree came into force. Companies must ensure that such devices are registered in the Directory; without this registration, from 1 January 2009, these products cannot be purchased or provided by the NHS.