Registration of medical devices in Italy becomes mandatory

Do you sell your medical devices in Italy? Manufacturers have until the end of December 2008 to register their devices as registration becomes mandatory on 1 January 2009. THIS INCLUDES ALL DEVICES, REGARDLESS OF HOW LONG THEY HAVE BEEN SOLD IN ITALY.

While the Medical Devices Directive allowed member states to transpose the directive into their national law and regulation and require registration/notification of Class IIb and Class III medical devices (and Directive 2007/47/EC extends this to include Class IIa medical devices), Italy requires registration of all classes of devices, including Class I. The European Commission has actually filed a formal notice (17 October 2008) contesting the Italian registration system. We do not believe the European Commission notice will alter the Italian legislation, but it is an interesting development.

As mentioned previously, the Italian Ministry of Health (Ministero della Salute) has modified their registration procedures to require medical devices (all classes) distributed in Italy to be registered into an Italian databank. Two Italian decrees have been issued describing these changes.

Decreto del Ministero della Salute 20 febbraio 2007 and Decreto del Ministero della Salute 20 marzo 2007,

The Decretos require manufacturers (or their designated entities) to register their medical devices in the Italian Ministry of Health database, if the medical devices are to be sold in Italy.

Obviously, a variety of regulatory documents for the device, such as the Italian labeling, et. al., need to be submitted. Once compiled, and posted to the Italian Ministry of Health Database, the review process by the Italian Ministry of Health may take up to 30 days, and then the entry would be "published" to the Italian Ministry of Health database so that it could be accessed by purchasers in hospitals. The registration provides a unique number for each device, and if the manufacturer wishes to list their devices on the database accessed by the National Health Service (NHS) hospitals, a repertorio fee would also be required per device.

The manufacturer may register directly or they can give the authorisation to another entity to do so.

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