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Italian Regulatory Authority

Regulatory Authority: The Direzione Generale dei Dispositivi Medici, del Servizio Farmaceutico e della Sicurezza delle Cure (DG-MED; Directorate-General for Medical Devices, Pharmaceutical Services and Healthcare Safety), under the Italian Ministry of Health (Ministero della Salute).

Link to the regulatory authority’s official website:https://www.salute.gov.it/new/it/tema/dispositivi-medici/

Database link:https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA

Regulatory Framework

The EU Medical Device Regulation (EU) 2017/745 (MDR) and Italian Legislative Decree 137/2022

Risk classification of medical devices and IVD products

In line with the EU MDR and IVDR.

Authorised Representative

EU Authorised Representative: Non-EU companies must appoint an EU Authorised Representative (AR), who must have a physical presence within the EU and assume legal liability.

It is not necessary to appoint a local representative in Italy; however, a locally registered agent in Italy must be selected to complete the registration in the Italian national database.

Essential Requirements for Market Access

Non-EU manufacturers must, through an EU Authorised Representative (AR), ensure that their products comply with the EU Medical Devices Regulation (MDR) (obtaining CE marking), establish an ISO 13485 quality management system, complete the technical documentation and clinical evaluation, implement UDI marking and register the SRN on EUDAMED, and complete registration in the Italian Ministry of Health’s NSIS national database, in order to legally enter the Italian market.

Documents required for registration

Labels and instructions for use in English and Italian
EU Declaration of Conformity
CE Certificate
Letter of authorisation and proof of identity of the manufacturer’s authorised representative

Registration Language

Labels and instructions must be in Italian.

Registration Process, Timeline and Official Fees

Registration Process:

Determine the device classification and complete the conformity assessment;
Prepare the technical documentation and clinical evaluation documentation;
Obtain the CE certificate;
Complete EUDAMED registration;
Provide Italian versions of the label and Instructions for Use (IFU);
Complete registration in the Italian Ministry of Health’s NSIS/Repertorio database.

No official fees are payable for registration in the Italian national database. Provided that EUDAMED registration has been completed, registration in the Italian Ministry of Health’s NSIS/Repertorio database can be completed in as little as one week.

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