On January 22nd, 2010, a decree from the Ministry of Health was published in the Italian Official Journal (D.M. 21 Dicembre 2009 ). The decree modifies and updates the Ministry Decree 20 February 2007, containing information for the registration of medical devices (in order to be marketed in Italy) in the database of the Italian Ministry of Health. This decree will come into force on February 6th.
After a long discussion between the Italian Health Authorities and the EU, Italy eventually decided to agree with the objections raised by many European Manufacturers who complained about the huge amount of information/documentation required for marketing their products in Italy, and about having to pay a fee for the registration onto the Repertorio, in order to be able to sell their products also to the National Health System, by taking part in public tenders.
The most important changes brought about by this new decree are the following:

1. If Manufacturers/EU Representatives have their head offices in a European Country (but outside Italy), the registration in the Database of Class I medical devices and of procedure packs will no longer be necessary, though Manufacturers can ask for the registration, if they wish so. They will also be able to sell these products to the National Health System without the need for any registration.*
2. All medical devices for which the registration to the Database is still mandatory can, as well, be sold to the Italian National Health System, after the registration to the Database, without being registered to the Repertorio. As a matter of fact, the registration to the Repertorio is no longer mandatory in order to take part in public tenders.*
3. The Ministry, however, will include in the Repertorio all those medical devices, if Manufacturers wish so, that were registered to the Database (after the Manufacturer pays the € 100,00 fee).*
4. The Ministry will also include in the Repertorio medical devices that do not have to be registered (see point 1.), if Manufacturers wish.*
5. Information and documentation required for product registration will be reduced: e.g., some information that was formerly mandatory will become optional.
6. As soon as the new decree comes into force (February 6th), Manufacturers will have 3 months to comply with the new regulations (i.e. until May 5th) for medical devices that have been marketed after May 1st 2007. But, for medical devices marketed in Italy starting from February 6th, the registration to the Database must be accomplished on the marketing of the device.

*The difference between being or not being registered to the Repertorio only lies in the fact that, if a MD is registered in the Database AND in the Repertorio, on the occasion of public tenders, hospitals and other public health services cannot ask manufacturers for info about their MDs, since these info are already registered in the Repertorio. On the other hand, if a MD is registered in the Database BUT NOT IN THE REPERTORIO, hospitals should first make sure that the Manufacturer complied with the liabilities to transfer the info to the Ministry (i.e. that the MD is actually registered in the Database), then they could ask Manufacturers for additional info, since they cannot find them in the Repertorio.(As a matter of fact, hospitals can only access the list of MDs that are registered to the Repertorio, while they cannot see the MDs that are only registered to the Database.)
So, the problem of not being registered to the Repertorio is no longer that you cannot sell your MDs to Italian public health services, but is more an issue of “visibility”.