Italy
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
Devices are regulated by the EU list of Competent Authorities.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the EU is required. 

ADDITIONAL INFORMATION: The Medical Device Directive is due to be changed in 2015.

Any Medical or IVD device that is to be sold in Italy must be registered with the Italian NSIS Database.  Non-European companies are required to have a European representative to take care of the registration process.  An exception is made for Class I devices where the European authorized representative is located outside of Italy, and the device is not made by an Italian manufacturer.

Last updated on March 17 2015.



Interested in obtaining fast market approval for your medical device or IVD in the EU? REQUEST A FREE QUOTE>

For more information on registration in the EU, check out the following articles on our blog:
5 Questions and Answers: Additional Regulations in the EU
4 Steps to Comply With EU Directive RoHS 2
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