[1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007.
These harmonized pieces of legislation include language related to the establishment of a Unique Device Identification System.
Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic.
[5] Following the passing of the Act, there were calls for the FDA to publish a timeline for the implementation of the UDI;[6] this was subsequently done.
Class III device labelers must submit to the GUDID for all existing products by September 24, 2014.
[10] As of July 2022, the EU has recognized four UDI-DI issuing agencies: GS1 AISBL; Health Industry Business Communications Council (HIBCC); ICCBBA, and Informationsstelle für Arzneispezialitäten (IFA GmbH).