Accreditation Agencies: We have three different accreditation agencies: GS1, HIBCC & ICCBBA who provide different kinds of barcodes, and they are not harmonized.
The Date Format: The length of the barcodes is different. The date formats are not harmonized, whether it is in European region or FDA region, and it should be in ISO 3166 format – which is year, month, and date.
Packaging Configurations: Packaging configurations have not been clarified, as you can see the production identifier is optional. So from a GS1 point of view, it is optional, but from the European point of view, it is mandatory because ISO 15223-1/2, and they mentioned that the product expiration date and lot number are mandatory. So, these are two contradictory directions, which can cause complications.
Direct Marking: Direct marking – where the size of the product and the amount of space which is available directly on the product may be of miniature size or of massive size. Where you can print a barcode directly, or a human readable interface, that direct marketing is once again a conflict which has not been clarified in most situations.
Unit of Use: The unit of use – sometimes you may come across a bag of 100 examination gloves, then are there UDI codes for all the individual items? Or, is it just for the box of those 100 gloves? This concept has never been clarified. Obviously, the manufacturer will be confused about how to do the UDI labeling and there are special cases that you see with products like procedure packs and some of the class 1 devices.
The strategies for UDI compliance requires the registration of the economic operator, registration of the device, and taking those registrations and aligning them with the product information, declaring the data elements, and the unique device identifiers.
I would recommend receiving clarification from a notified body or another agency, getting transparency in terms of how the certification works with your agency and with the national competent authority and how to declare that information. Go through the vigilance process of setting up the quality system, which is regarding the post market surveillance or the clinical evaluation.