Regulatory Authority
Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico – Ministry of Health.
Classification
Class I (standard, sterile, measuring, reusable), Class IIa, Class IIb, Class III.
Quality system
ISO 13485:2016 and requirements of Art. 10 Reg. (EU) 2017/745.
All Medical Devices must bear CE marking pursuant to Regulation (EU) 2017/745 (MDR) and are subject to registration in the Ministry of Health database.
In the case of an extra-EU manufacturer, it is necessary to appoint an Authorized European Representative (Mandatario).
Manufacturers intending to place CE-marked Medical Devices on the Italian market and European Mandatarios must register with the Ministry of Health database to notify device data for inclusion in the Repertorio dei Dispositivi Medici (RDM).
Applicant
Authorized Representative or Manufacturer.
Timelines and Costs
- 30-45 days for administrative registration.
- Registration and maintenance in the Repertory are subject to ministerial fees (DM 14 March 2023).
Validity
- The CE Certificate validity is generally up to 5 years for devices subject to Notified Body intervention.
Language of Documentation and Labelling
- Technical Documentation: may be drafted in English; Italian is required by authorities upon request.
- Labelling and IFU (instructions for use): Italian.
- Translations: must be faithful to the original (sworn only where required for official acts).
Useful information
- The website of the Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico of the Ministry of Health is the reference point for updates. In particular, Office 5 of the same Directorate is the competent body for market surveillance and vigilance activities.
- In 2026, the Classificazione Italiana dei Dispositivi Medici (CID) comes into force, required for registration in the Ministry of Health’s national Database, alongside EUDAMED. This system is harmonized in the first 7 levels with the European EMDN nomenclature.
