Italian Medical Device Registration: The Role of the Ministero della Salute

Accessing the Italian medical device market requires full compliance with the EU Medical Device Regulation (EU MDR) and adherence to specific national obligations defined by the Italian Ministry of Health (Ministero della Salute). The key national step is registration in the dedicated Italian database.

---

1. EU Compliance Prerequisite (CE Mark)

Before focusing on national Italian requirements, the device must first satisfy the pan-European framework:

• CE Marking: The device must be appropriately classified (I, IIa, IIb, or III) and bear the CE Mark, meaning it complies with the EU MDR and has passed the necessary conformity assessment (by a Notified Body for high-risk classes).
• EU Authorized Representative (AR): For non-EU manufacturers, an EU Authorized Representative must be designated to handle regulatory responsibilities and communications within the EU, including the Italian Ministry of Health.

---

2. Mandatory National Registration

Italy maintains a national database for all medical devices placed on its market, ensuring national surveillance and traceability.

• Ministero della Salute Database: Manufacturers (or their AR) must register their devices in the Italian Medical Devices Database (also known as the Repertorio). This applies to virtually all device classes.
• Database Purpose: This registration is crucial for the Italian authorities to monitor the market and is specifically required for devices intended for distribution or supply to the Italian National Health Service (SSN).
• Registration Details: The notification requires comprehensive device data, including the CE certification details, manufacturer information, and the Unique Device Identification (UDI) codes.

---

3. Language and Vigilance Obligations

Italian law imposes strict requirements regarding language and post-market safety reporting:

• Italian Language Mandate: All safety-critical documentation intended for the user, including Instructions for Use (IFUs), device labeling, and promotional materials, must be provided in the Italian language.
• Vigilance Reporting: Serious incidents and Field Safety Corrective Actions (FSCAs) must be promptly reported to the Ministry of Health via the dedicated Italian vigilance system, ensuring patient safety is monitored locally.