The Ministerial Decree of February 20, 2007 set up the new database of medical devices, also in view of the establishment of a European database. The decree governs the new arrangements for the registration of products in the database by manufacturers, provided for by Legislative Decree no. 46/97, and registration in the Repertory of devices sold to the National Health Service provided by art.1, paragraph 409 of Law No. 266/2005 (as amended by Legislative Decree No. 1 of the 24 January 2012).
The database of medical devices collects information related to all medical devices released in the Italian territory by domestic manufacturers. However, the registration of medical devices by European or non-European manufacturers who wish to distribute their medical devices in Italy is limited to those belonging to classes higher than I.
The database of medical devices is an important instrument for market surveillance, as well as for the supervision of medical devices in the country.
The Repertory is a subset of the database. The registration of the devices in the Repertory allows for the visibility of information relating to these devices to all operators of the National Health Service. This characteristic facilitates manufacturers in tenders. On this occasion, additional documentation on the medical device, object of the tender, is not required from the manufacturer because it can be found via the Repertory itself.
The regulations for the method of enrolment in the database and the Repertory have been determined by the Decree of the 21 December 2009, “Changes and additions to the Decree of February 20, 2007 laying down “New methods for the requirements for the registration of active implantable devices as well as for registration in the Repertory of Medical Devices “. In March 2012, moreover, the fee of € 100.00 was abolished hitherto required for registration in the Repertory.