UDI (Unique Device Identification): HIBCC or GS1?

Hey folks,
I step in here because I´m having a problem with the internal release of GS1 as our UDI supplier.
Our QMR demands at least a certified QMS. But we were informed that they have none and points out that GS1 is accredited as an issuing agency in Europe and anyway is used by so many medical device companies. However also the publication of the designated entities in the Journal of the European Union seems to be not sufficient. But I do not give up, because I'm aware that so many other companies also use the service of GS1 and also the accreditation will probably be based on something. So, it would be great to know if you considered the UDI issuing entity as a) supplier or even as b) "no alternative and given from above" and in case of a) what criteria (probably risk based?) you have defined for the qualification of suppliers like the issuing entity.
Thanks Norman

Norman said:

Our QMR demands at least a certified QMS. [...] also the publication of the designated entities in the Journal of the European Union seems to be not sufficient.

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This is a fine example of unnecessary rigidity built into the QMS.

Hello,

We are a French manufacturer of medical device in class II.a, and we want to set up a coding system for UDI. The problem is that we cannot choose a standard from among GS1 and HIBC and determine which it is the most suitable for our product.

relative to our turnover:
1) GS1 fees are: € 317 (Membership fees) and € 317 (Annual fee fees).
2) On the other hand for HIBC, the LIC application fees (1000$) are the only financial transaction to be done once and for all, is that normal?

So, will the cost depend on the volume of codes?

Also, there are several manufacturers who have changed their coding system from HIBC to GS1.

What do you think is the better Standard between the two?

Thank you all for your interesting responses !

Back in the day, GS1 used a model where you paid for a limited number of codes. If you ran out, you were forced to go to the "next level" of codes containing a greater volume. This model has since changed and is now more of a HIBCC model of one annual fee for unlimited UDI's.

In 2016, we went with HIBCC as we required a few UDI values and HIBCC made more sense to us. We did explore GS1 recently as we had a request by a vendor who used it in their system. During our examination, we found that the GS1 system wasn't as easy for our team to work with, and therefore reached a conclusion to stay with HIBCC. I can say that HIBCC has been excellent to work with and we have had zero issues in setting things up, training staff and maintaining our system. We did dabble in GS1 for a brief time for a private project and although they were great to work with, we found their product support a bit slower.

Thank you @Edward Reesor for sharing with us your very intersting experience.

In fact, I contacted GS1, this is the message I received from them today:

"When you join GS1, you will obtain a coding capacity, if you reach the end of this capacity you will have to request an additional company prefix which will be 50% of the amount of your annual fee (half price)".

So if I understood correctly they don't offer unlimited UDI's?

In addition, I would like to know your opinion since you have worked with the 2 agencies. Indeed, among our products, we have only one type of medical devices which requires an UDI. So, we will need only one product code. For you, what is the best system to adopt for us?

For GS1, you get a block of identifiers (GTINs) in the amount that you purchase, it's definitely not unlimited. For example, you might purchase 999 DIs to start and be assigned 0999-000 to 0999-999, and then if you need more, you buy another block a few years later in which case it might be 2049-001 to 2049-100 for example. There's no benefit to sequential numbers so it really doesn't matter what the identifier is other than maybe internally to spot blatant errors, I suppose.

In my opinion, I've seen GS1 is far more widely accepted in the Medical Device world than HIBCC, perhaps because HIBCC is relatively unknown outside of Med Device. Company's that generally choose HIBCC first are because it's a lot less expensive for company's needing LOTS of DIs. Essentially a one time based on sales vs GS1s Initial Fee + Annual Fee.

From a clarity standpoint, I think GS1 is better and more error proof but it's just a financial and quality decision at that point. If you're a contract manufacturer or OEM, chances are your customers may want both.

Edward Reesor said:

Back in the day, GS1 used a model where you paid for a limited number of codes. If you ran out, you were forced to go to the "next level" of codes containing a greater volume. This model has since changed and is now more of a HIBCC model of one annual fee for unlimited UDI's.

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I have not seen anything like that. Do you have a link? I still range on the US Site: GS1 Company Prefix - UPC - GS1US Ecommerce

When we required a few GS1 numbers initially, we didn't get a prefix but were given 10 UDI (which came with 10 additional codes for case quantities). We held those for several years before we explored a need for more numbers. During that period, our revenue had increased which placed us in a category that was eligible for more UDI's, however we had to apply for a company prefix at that time. In order to do so, we had to surrender those original 10 numbers. Our project that required GS1 was cancelled ,however.

Edward Reesor said:

When we required a few GS1 numbers initially, we didn't get a prefix but were given 10 UDI (which came with 10 additional codes for case quantities). We held those for several years before we explored a need for more numbers. During that period, our revenue had increased which placed us in a category that was eligible for more UDI's, however we had to apply for a company prefix at that time. In order to do so, we had to surrender those original 10 numbers. Our project that required GS1 was cancelled ,however.

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Ah got it, sounds like you bought 10 GTINs outright rather than 10 prefix-based GTINs. In my above post to Nicholas, I am referring to assignment of ranges of GTINs for use by a single manufacturer only. I thought you were referring to GS1 had gone away from range assignment to truly unlimited like HIBCC, but that's not the case. We're on the same page now.

Anyone try QARAD .com for their e-IFU and e-Labelling?