Will an FDA UDI be compatible with a European MDR UDI?

Nancylove

Starting to get Involved
Does anyone know whether an FDA UDI will be (or can be) compatible with a UDI required by the EU MDR? If not, will manufacturers be able to label their device with both UDI's?
 

rob73

looking for answers
As far as i know there are three UDI standards that will be accepted in the EU, GS1, HIBCC, ICCBBA. As i understand it the FDA will also recognise these, so from a regulatory point of view all looks okay. BUT It will also depend on who you are selling to, the UK NHS for example are trying to standardise on GS1's GTIN, but will accept HIBCC. I guess if anyone is going to throw a spanner in the works it will be the customer, as usual.
See also this thread UDI (Unique Device Identification): HIBCC or GS1?
 

Nancylove

Starting to get Involved
I agree with that. However, my question is, if you have a product that is cleared for use in both the US and the EU, after a UDI (actually GTIN) has been assigned to that device in the U.S., can the same UDI (GTIN) be used for that device in EU? You can imagine the difficulty of having more than one UDI for a particular device for different markets.
 

snowball852

Starting to get Involved
I agree with that. However, my question is, if you have a product that is cleared for use in both the US and the EU, after a UDI (actually GTIN) has been assigned to that device in the U.S., can the same UDI (GTIN) be used for that device in EU? You can imagine the difficulty of having more than one UDI for a particular device for different markets.

My understanding is that it will depend on who the EU designates as acceptable providers of the UDI. If they designate a provider that does not include our current provider, then my understanding is that we will have to have two UDIs on our label. But, if the provider is the same, then you can have one.
 

moounir

Involved In Discussions
Hi @Nancylove ,

I agree with snowball852. The current problem is the fact that no official organism was approved to provide the UDI number. But anyway there will be some differences between the US and Europe. So even if your UDI is similar, there is additional information that you'll need to provide. Registration will be on a different database.

So you'll need to prepare for that with some unknown information for now. We hope this will come early next year.
But you should also understand that there is a transition for the UDI. You can look at chapter 122 of the MDR. You'll see that higher is the class of your product, shorter will be the transition.

I hope this helps you to put in place a good strategy.

Regards.
 

snowball852

Starting to get Involved
I recently noted that Article 120(12) states: "Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities."

and per Article 123(3): (i) Article 120(12) shall apply from 26 May 2019.

So, looks like if the EU hasn't designated issuing entities by 26 May 2019, then GS1, HIBCC, and ICCBBA are the issuing entities (of which at least GS1 and HIBCC are also for US, meaning we can use the same GTIN.
 

duinyk

Involved In Discussions
I recently noted that Article 120(12) states: "Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities."

and per Article 123(3): (i) Article 120(12) shall apply from 26 May 2019.

So, looks like if the EU hasn't designated issuing entities by 26 May 2019, then GS1, HIBCC, and ICCBBA are the issuing entities (of which at least GS1 and HIBCC are also for US, meaning we can use the same GTIN.

Since GS1 has now been officially appointed as an EU UDI issuing entity this means for a device with an existing US GS1 UDI (GTINs) these same ones can be used for EU UDIs right?
 
Top Bottom