Steve Kent Other than the US, it will depend on where else you intend to market your products. I believe it is a requirement; or it is becoming so, in Australia for GS1 GTIN barcodes for medical devices, and I think a few other countries. There are current timelines in the UK for their adoption on medical devices for suppliers to the NHS (starting by suppliers joining GS1 by 31.3.16 – to get their GTINs). As with the US, the proposed EU Medical Device Regulations (if they ever get published!) will require a device UDI – in other words a likely requirement for GS1 GTIN barcodes – but there will be a transition period (3 years?).

Bill Watson My company recently executed UDI compliance. Steve's got some great comments. Once you've gone through the pain of implementing UDI, you might as well start rolling it out for other markets and leverage UDI and barcoding through the production process to facilitate job order tracking, etc.

Gautam Sharma Thanks Steve and Bill for great answers!!

Yes . This system of barcodes has been made mandatory by DGFT for all the medical devices being Exported.

Teri Demarco I have been working with the UDI initiative here in the US for about 5 years. I work with a company that does barcode verification/print quality inspection systems . It is required. It is being implemented by medical device classes. Medical Device Class 2 are required to be ready by 9-24-16. If I can help anyone with the barcodes or have a questions I can try to help.

Stephane Morvan Well, this is about tuning in into your customer processes.

Most Medical products have their own serial or lot number, have an expiry date and a specific part number for each variation (sizes) etc... Many bits and pieces of information that are essential to the correct resupply of your products into a hospital, not to mention traceability. In that case, the use of a GS1-128 barcode will integrate all these in a single, standard barcode readily scanned at the point of use (or near) in European hospitals.

So IMHO, the low complexity and cost associated with the GS1 barcoding system makes this a must have, if not for customer friendliness, to be on a par with your competitors. Of course, if your product or its packaging is too small to accommodate a GS1-128 barcode, this is another issue altogether - but this is definitely something to keep on your issue deck.