Medical Device Registration in
Italy
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
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:
Yes
License Validity:
5 years
Special Notes:
Labels and IFUs should be in Italian