UDI (Unique Device Identification): HIBCC or GS1?

There are actually 3 different 'issuing authorities' for UDI numbers. The 2 main ones are GS1 and HIBCC. These 2 standards groups differ in their history and coverage. GS1 was the UCC (all retail barcodes around the world since 1970’s) and has aggressively moved to support healthcare’s move to barcode standards over the past few years. HIBCC was started 10+ years later and focused on the US healthcare companies. European regulators (not just the Dutch) and pretty much everyone else, specify GS1. It really is global.

The current trends for registering products seems to be heavily in GS1's favor. Better than 10 to 1 the last time I looked. This is primarily because medical device manufacturers want to sell around the world and that is what their customers want.

Regardless of which standard you use and buy your UDI number from, you are required by regulations to follow that standards minimum quality grade for barcodes. Both currently require a minimum of ISO grade 2 (ANSI C). You can find your grade by using a ISO barcode verifier. Since UDI barcodes are dynamic and have fields of data such as lot, expiry and serial # the barcodes will change from package to package, it is recommended that manufacturers have a verifier at hand when printing so they can check before and after a run. It is also important to record these checks just as you would other product attributes.

So, pick the standard right for you, follow the standard, do it right and record everything. No problems, and that is what we all want.

miken99 said:

It really is global.

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GS1 actually operates as a sort of consortium of national operations. When I contacted GS1 Australia on behalf of a client regarding the US UDI obligations for a class II device, they hardly had the necessary expertise/knowledge (they actually admitted it), they didn’t have a matching “package” to offer, and it ended up with us having to either sign up with GS1 US or with HIBCC (which, as far as I know, conducts all its operations out of a single site in the US).

All probably true. The various organizations in different countries are 'member organizations' which have been established to coordinate that countries products identification.

UDI is relatively new so I would expect to see different countries at different points on the learning curve. US is ahead at this point, Europe is setting up with some variances taken to correct previously existing conditions in the med device market. I am not sure about what Australia will follow but they will.

If your customers will accept HIBCC now and in the future then it is an option for you.

After "Brexit" the UK will probably stay with just GS1, the EU however will accept several issuing companies?

In the US, GS1, HIBCC and ICCBBA are the only issuing authorities for UDI's. They each have their own niche and there own barcode protocols/specs that will work together in the UDI community. Most of the FDA registered UDI's are now GS1.

In the EU, it is different. Various 'notified bodies' such as UL are the issuing authorities for UDI's (they may call it something slightly different). My opinion is that GS1 specs will be used for barcoding as well as ICCBBA.

In the UK, you are probably right. They will also lean toward GS1 for barcode specs. I am not sure what their plan is for issuing UDI's. TBD Their overall system may be different than the US and EU however. A little more complex than the US and a lot less complex than EU. 60 data fields vs. 80 data fields vs. 160 data fields approx.

Above is just my opinion. There is still a lot of flesh to be put on the bones

miken99 said:

Various 'notified bodies' such as UL are the issuing authorities for UDI's

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Reference?

Notified bodies are not UDI issuing entities (US: issuing agencies), and don't have involvement with the UDI registration or assignment processes. UDI-DIs are issued by GS1, HIBC and ICCBBA for the US and EU.

After a manufacturer has registered as an economic operator (as defined in Annex VI Part A Section 1), they are issued a Single Registration Number (SRN). With the SRN, the Manufacturer is able to prepare the EU Declaration of Conformity for the device as described in Annex IV. If the device classification requires a Notified Body to be involved in the conformity assessment, the SRN enables the manufacturer to submit the application to the Notified Body.

I have a question about the serialization of HIBCC UDI because we have a lot of products and we are not going to create the UDI one by one.
I would like to know if HIBCC have a solution to generate the UDI automatically in production chain.

I would call them up. I have found HIBCC to be extremely helpful with questions like this one.

I have already sent them an email about it but I have no answer for this subject.