• What is the Catalogue of medical devices?
• How is the registration of medical devices carried out?
• Can I export medical devices into theEEC market which have been regularly imported from an extra-EU country?

What is the Catalogue of medical devices?

Before entering the Italian market, each medical device has to be registered into the Database (and possibly in the Catalogue) of the Ministry of Health. This operation has to be carried out by the manufacturers themselves or by a delegated subject. The Database and the Catalogue of the Medical Devices make up a system, made available by the Ministry of Health (and already provided for by Law no. 266/2002), mainly used as a market surveillance tool, both to help sector operators in their economic assessments and for vigilance operations on the MDs marketed in Italy, as provided for by the European Regulations.

How is the registration of medical devices carried out?

The criteria and the methods for the registration of the MDs are dictated by Decree December 21st 2009, "Changes and integrations to decree February 20th 2007 containing New methods to comply with the registration of active implantable devices as well as the registration into the Catalogue of the Medical Devices". (qui se vuoi si può mettere il link al decreto)

Can I export medical devices into theEEC market which have been regularly imported from an extra-EU country?

If the manufacturers are located outside the EU, they have to have a representative in a EU country  (a sort of legal representative which acts on their behalf in the EU).  Both the manufacturers and their representative have to be registered into the Database. Besides, the MDs arriving in Europe has to be EC-marked and to be registered into the Database according to the methods and criteria established in Decree December 21st 2009, before they can be sold.