Medical Device Registration In Italy

All medical devices marketed in the EU must bear the CE mark to certify conformity with EU law. In Italy, the manufacturer must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. The obligation to register with the new modalities concerns medical devices marketed in Italy for the first time starting from 1 May 2007, and in particular:

• Class I, IIa, IIb and III devices.
• The kits and assemblies.
• Active implantable devices.

Entities making the registrations: 

The registration of a device within the Database / Directory of Medical Devices system can be requested by:

• Manufacturer
• Representative
• Other delegated subject by the manufacturer and representative

A single AR may only represent the manufacturer for each type of device. Thus, to enter the medical devices market, manufacturers of medical devices are required to appoint an AR, which will assist with all the details regarding the registration process and assist in completing requirements under the Italian regulation. As a non-EU manufacturer of medical devices, the manufacturer’s legal representative can appoint a “delegate as person or company” to register their product with the Italian database. This delegate will communicate with the Italian Ministry of Health on the manufacturer’s behalf. The online registration can be found on the Ministry of Health website: Ministry of Health Timeline for registration: 1 month