The National Classification of Medical Devices (CND)

Class I devices without sterile packaging, measuring function, or reusable surgical purpose do not require Notified Body intervention. However, for Class I devices that are sterile, have a measuring function, or are reusable surgical instruments, the Notified Body is involved, but only for aspects specific to sterility, measurement accuracy, or reuse-related requirements. For higher-risk devices in Classes IIa, IIb, and III, the Notified Body’s involvement is mandatory regardless of special features, ensuring compliance with safety and performance requirements.

In Italy, the labeling requirements for medical devices are governed by the European Medical Devices Regulation (MDR) 2017/745, as Italy is a member of the European Union. The MDR sets out the general principles for labeling medical devices across all EU member states, including Italy.

Clinical evidence is defined as the clinical data and results of the clinical evaluation relating to a device and must be of sufficient quantity and quality to allow a qualified assessment of the safety and achievement of the intended clinical benefits.

The results of the evaluation are documented by the manufacturer in a report, the Clinical Evaluation Report (CER), which must be included in the technical file of the device .

Current legislation establishes that public and private healthcare workers, based on what they find in the course of their activities, are required to promptly communicate, and no later than 10 days, to the Ministry of Health any serious incident, even if only suspected, involving a device.

Health Advertising Licenses

In particular, article 14 of Legislative Decree 137/2022 places the obligation on distributors to register in the national database if they make medical devices available on Italian territory.