Italy

Ministry of Health: 

Ministry of Health

Regulatory Authority:       

Directorate–General for Medical Devices and Pharmaceutical Service 

Medical Device Regulation:

EU Medical Device Regulations 2017/745

Official Language:   

Italian

Classification:        

Class I, IIa, IIb and III

Registration Process:       

• Determine the device classification
• Appoint an Authorized Representative and Notified Body
• Prepare the CE Technical File and submit it to the Notified Body
• Notified Body will carry out the Conformity Assessment and send the report to Competent Authority
• Once approved, the device can be marketed in Italy.