Medical Device Registration in


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:   



Class I, IIa, IIb and III

Medical Device Registration in Italy:       

  • 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.

Documents Required:      

  • CE Certificate
  • Technical File
  • Declaration of Conformity
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • QMS certificate
  • Labelling

Applicable QMS:    

ISO 13485

Registration Timeline:      

30 – 45 days

Authorized Representative:        


License Validity:     

5 years

Special Notes:       

Labels and IFUs should be in Italian

Want to know more about this registration process?