Italian Medical Device Regulatory Body: Overview and Registration

Overview of the Italian Medical Device Regulatory Body

The Ministry of Health (Ministero della Salute) is the competent authority responsible for the regulation, supervision, and market surveillance of medical devices and in vitro diagnostic (IVD) medical devices in Italy. Specifically, the Directorate General for Medical Devices and Pharmaceutical Service (Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico) oversees these activities.

Key Roles and Responsibilities

1. Implementation of EU Regulations: The Ministry ensures the application of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) within the Italian territory.
2. National Database Management: It manages the Banca Dati dei Dispositivi Medici (BD/RDM), the national registry where all devices must be registered before being placed on the market.
3. Market Surveillance and Vigilance: Monitoring the safety of devices on the market, managing reports of incidents, and implementing field safety corrective actions.
4. Clinical Investigations: Authorizing and supervising clinical trials for medical devices that do not yet have a CE mark or are used outside their intended purpose.
5. Advertising Regulation: Authorizing health-related advertising for medical devices to the general public.

Registration in the National Database (BD/RDM)

While the European database EUDAMED is still being fully implemented, registration in the Italian national database remains mandatory.

• Who must register? Manufacturers (or their authorized representatives for non-EU companies) must register their devices.
• Requirements: Devices must have a valid CE Marking and comply with language requirements (labeling and instructions for use must be in Italian).
• Unique Device Identification (UDI): The registration process integrates UDI requirements to ensure traceability.

Access and Compliance

Registration in the BD/RDM is a prerequisite for:

• Placing medical devices on the Italian market.
• Participation in public tenders for the National Health Service (SSN).