UDI (unique device identification)

Unique device identification is a system of codes, on the label and in a database, that identifies a device model and, where required, the production unit.

The EU MDR Articles 27 and 28 and the US FDA UDI rule both require a unique identifier. The identifier has a device identifier that points at the model, and often a production identifier such as lot, serial, expiry or manufacture date. The data are submitted to a database: Eudamed in the EU, GUDID in the United States. Labelers are responsible for issuing and maintaining the data.

UDI is not a substitute for traceability inside your own production records. It is the public identification. Your DHR and distribution records should be able to connect a complaint to the UDI of the unit involved.

HAVGATE does not issue UDI codes or submit them to a regulator. Complaint and CAPA records should store the UDI or lot you are investigating so the quality system and the registration database tell the same story.