Unique Device Identification

Unique Device Identification (UDI)

Unique Device Identification (UDI), is used to uniquely identify devices and intends to ensure better traceability and patient safety. The UDI is based on the UDI system, a globally harmonized identification system for medical devices. Part of the UDI code is the device identifier, which is created by the manufacturer, and the product identifier, which is assigned by the regulatory authority (e.g., the European Medicines Agency).

The device identifier contains information such as the manufacturer, model, expiration date and serial number of the product. Thus, each model is assigned a distinctive numeric or alphanumeric code.

This code is also necessary for unique identification of the medical device and inclusion in the UDI database. Therefore, the manufacturer must include the code in all relevant certificates and in the EU Declaration of Conformity.

If your product does not have a UDI, it must be uniquely identifiable by other means, such as a product code or catalogue number. This identification must allow unambiguous traceability. The implementation of an appropriate system for creating, assigning and affixing such a code must be considered when implementing the MDR.