UDI (unique device identification)
Short definition
UDI (unique device identification) is a numeric or alphanumeric code, created according to international standards, that allows a medical device on the market to be identified unambiguously.
In plain language
It is defined in Article 2, point 15, and regulated in Article 27 of Regulation (EU) 2017/745. It combines a model identifier (UDI-DI) with a production identifier, such as lot or serial number (UDI-PI), and is assigned through entities designated by the European Commission, such as GS1. It facilitates traceability, recalls and incident reporting.