UDI

Medical devices, from a syringe to a hip implant, carry a code that identifies exactly which device it is and which batch it came from, so a faulty one can be traced and recalled quickly. The code has two halves: one for the model, one for the particular item, with lot, serial number and expiry date. This system of codes is called UDI, short for unique device identification.

The model half is called the device identifier; the item half is the production identifier. Both are printed on the label as a barcode and as plain text. Codes come from an issuing agency such as GS1 or HIBC, so a UDI on a label is often a GS1 or HIBC barcode with extra structure.

Rules about which devices need a UDI, and how, differ between the EU, the US and other markets, and they change. This entry explains the term and is not regulatory advice; check with your regulatory contact before you label or ship.