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.
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.
Yes, that is correct.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?