Regulatory Open Forum

For the PI portion of the UDI, once generated by the vendor (GS1, for example) based on production information, how is it transferred to the label in production? 

Or, in order words, what is the interface between the GS1 System and the actual production? 

I am totally missing this step. 

Hello Anon

Assuming GS1 is your issuing agency, they'll provide you a block of GTINs and you'll assign a GTIN to each of your product models to serve as the UDI-DI. The UDI-PI will be made of all the production identifiers you use on your labels. Here's a sample:

The number following the (01) is the GTIN. This particular device has three production identifiers. The (17) identifies an expiration date, in YYMMDD format. The (10) identifies a lot number. The (21) identifies a serial number.

Your device may have more, fewer, or different production identifiers. Whichever ones you use, you'll prefix them with the appropriate "Application Identifier" (the two digits in parentheses), string them all together, and use the whole bunch to generate the barcode.

Assuming you're printing barcodes as your AIDC? For that you just need to have barcode generating software integrated with your label printing software.