Unique Device Identification (UDI)?

A UDI is a unique numeric or alphanumeric code and consists of two parts:

A Device Identifier (DI): mandatory part for the unique identification of the medical device or IVD.
A Production Identifier (PI): variable part with manufacturing data.

Creating a UDI

1

Order GS1 article codes/GTINs

Assign a GS1 article code to each version or model in order to uniquely identify the product. Use the GTIN-13 for this purpose. Because the healthcare barcodes (GS1-128 and GS1 Data Matrix) have 14 positions, you manually add a leading zero. Or you can use indicator digits to identify packaging levels, in which case you also get 14 positions.

2

Adding manufacturing data

Depending on the requirements of the legislation; add production date, expiry date, batch/lot number or a serial number. Use Application Identifiers (AIs) for this purpose. In the case of software, a software version can be added.

3

Place UDI in text form and as a symbol on the product

In healthcare, the GS1-128 and the GS1 DataMatrix are the two permitted barcodes worldwide. The manufacturer of the medical device chooses which barcode needs to be on the product.

Creating a UDI - UDI
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