UDI: GS1 or HIBC ???

#1
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 !
 
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#2
Have you considered looking at the other two UDI issuers (ICCBAA and IFA GmbH)?

I found the fees from HIBC to have conflicting information and it wasn't clear whether there are any recurring costs and/or what these could be as you've said above. I found the overall fees to be much the same when you add them up, so it is probably a weigh up between which standard seems most sensible (personally GS1 and IFA make the most sense to me) and understandable and any hidden charges (IFA are really clear on these, with fees per product pre-allocation, first registration, product changes, contract violation and product deletion charges all being listed - the others do not list this).

I also don't know whether you need to factor into it where the UDI issuer is, but HIBC and ICCBAA are both based in the US, with GS1 being in the UK and IFA GmbH being in Germany (DE).

If you're just asking for my personal preference between the two above, I'd go with GS1. I'd recommended IFA if you include all of the issuers.
 
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