The US requirements for Unique Device Identification (UDI)

An update and short FAQ guide for members in relation to the new US requirements for UDI.

In 2013, GS1 became an authorised issuing agency for unique device identifiers (UDIs) by the US regulator, the Food and Drug Administration (FDA). This means that GS1 members can use GS1 Global Trade Item Numbers (GTINs) on their products (in this case medical devices), to uniquely identify, track, and trace, medical devices through every step of the product lifecycle, supply chain and patient pathway.

GS1 UK, as one of 115 GS1 Member Organisations, have a requirement to ensure that we have accurate information of members that are using GTINs to identify medical devices being supplied to the US for sale and use. 

Between now and 30 September 2021, we are required to contact each of our 50,000+ GS1 UK members to confirm whether they are using GTINs on any medical devices supplied to the US market.


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