Ministero della Salute

Manufacturers that place on the market In vitro Diagnostic Medical Devices in Italy under their own name are required to provide the Ministry of Health with all data necessary to identify such devices (Art. 10 of Legislative Decree 332/2000) on in vitro diagnostic medical devices).

Manufacturers may choose one of the two following options to submit the forms:

• use the appropriate Online forms for company registration and medical device description to send data directly to the Ministry (recommended option)
  
• download the forms (for company registration and in vitro diagnostic medical devices description) and then send them by fax or post (in this case senders are required to enclose a covering letter)
  
  
  • Company registration form (pdf,9 KB)
    
    
  • In vitro diagnostic medical device description form (pdf, 12 KB)
    
    
  • Authorized representative declaration form (pdf, 12 KB)
    

You are reminded that to duly comply with registration methods for in vitro diagnostic medical devices, it is necessary to send the company and devices data forms to the Ministry.
The forms should be sent to:

To allow the user to provide the correct information regarding Group and Type of the device (information required in regardless of the way data is sent), it is possible to download the list of in vitro diagnostic medical devices Groups and Types according to the EDMA Classification.

Furthermore, in the above-mentioned Art. 10 (paragraph 2), it is required for in vitro diagnostic medical devices referenced in Annex II, and devices for self-testing to send also the label and the instructions to the Ministry of Health. 

In order to facilitate the delivery of such documentation, it is pointed out that: labels and instructions for use can be sent, similarly to other required data, by filling the online forms, or by post or fax, or by e-mail (dgfdm@postacert.sanita.it).

Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorized representative based in the European Union. The authorised representative based in Italy must provide all device-related data to the Ministry of Health (Art. 10, par. 3 of Legislative Decree 332/2000).

As a provisional measure, until the activation of the European databank, manufacturers and/or authorised representative not based in Italy and that are already registered in their own country, are required to provide data related to the devices they intend to place on the market in Italy (Art.10 par. 6 Lgs. D. 332/2000).

In order to establish a suitable market vigilance system and in view of the creation of a European databank, concerned companies are invited to fulfil as soon as possible the obligations required by the legislation in force.