MARKETPLACE
Price setting
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Major changes in medical device procurement are taking place in the first half of 2007. This includes the creation of an exhaustive database of the products for purchase by public hospitals. Working within the constraints of Italian budget law of 2007, the Italian Ministry of Health (MoH) is establishing a list of prices that will be used as the basis for tenders to supply the Italian national health service, the Servizio Sanitario Nazionale (SSN). The prices are being set by taking account of the unit purchase price paid by the SSN during 2005 and 2006. These price data were collected from regional health authorities and medical device suppliers during the first months of 2007 in a survey covering approximately 500 categories of medical devices. These changes in medical device procurement are potentially dramatic. At the time of writing, a national decree containing the list of medical devices and their reference prices is pending. Therefore, it is too early to determine the real impact of these changes on the Italian market.
New device classifications
The Medical Device Commission (CUD) has approved the second version of the Italian medical device classifications, Classificazione Nazionale Dispositivi (CND). CND is a hierarchical, multilevel, “tree-like” structure of 22 mutually exclusive main categories and 144 groups. In large part is it aligned with the international nomenclature, that is, the Global Medical Device Nomenclature (GMDN). CND will be used for all activities related to the procurement of medical devices in Italy, as well as medical vigilance and postmarketing surveillance activities. At least once a year, CUD with an “ad hoc” working group will update the classification list after consultation with regional health authorities and industry associations.
Fee for notifications
In accordance with the Italian transposition laws for the Medical Device Directive (93/42/CE) and the Implantable Active Medical Device Directive (90/385/CE), the MoH is creating a medical device database to hold information on new medical devices and medical devices already on the market. Manufacturers, authorised representatives and others responsible for placing medical devices on the Italian market will transmit notification information in electronic format through the MOH’s website: www.ministerosalute.it. The electronic process of notification provides the assignment of an identification (ID) number for subscription in the medical device database. This ID number will be cited in vigilance reports and any kind of communication between manufacturers and the MoH. Notification is not free of charge. A fee is payable for every medical device technical dossier registered in the database. Those responsible for notifications to the Italian MoH must provide the following information:
- general medical device data, including, brand name, model and identification code
- medical device classification, including, risk class, and the CND and GMDN classifications
- information on CE-marking certification, including, number, expiry date and Notified Body
- technical information, including, sterilisation method, materials, biological tissues or animal-derived substances, presence of drugs, inform-ation relating to the primary packaging materials
- technical documentation, including, labels and instructions for use
- commercial and sales data such as price and volume.
Timing
From 1 August 2007, medical devices placed on the Italian market for the first time after 1 May 2007 cannot be acquired or used by public hospitals without their ID number and if they are not registered in the medical device database.
From 1 January 2009, medical devices placed on the market before 1 May 2007 will be assigned an ID number so that they can be supplied to Italian public hospitals. This means that already notified medical devices must be registered again in the new database.
Currently, these changes do not apply to in vitro diagnostic products and custom-made medical devices. However, a new system for notifying these products will be established in the near future.
Full details of these procedures, the laws, decrees and the forms can be viewed and downloaded in Italian from: www.ministerosalute.it/dispositivi
Information supplied by Assobiomedica, the Italian medical device and in vitro diagnostics association, via Giovanni da Procida 11, I-20149, Milan, Italy, tel. +39 02 3453 1165, e-mail: assobiomedica@assobiomedica.it; www.assobiomedica.it
