EU MDR Translation of Product Name

PVC Barbie

Starting to get Involved
#1
We have a trademarked product which we are selling in EU. Under the new requirements to translate into all languages for the countries being sold into, I'm looking for clarification on whether or not the product name has to be translated. For example, product name "Gizmo* mini" followed by a descriptor (which I understand has to be translated), does the "mini" portion of the name have to be translated since its not the trademarked portion? If we trademark the whole name "Gizmo mini*" would that change anything?

Thanks in advance!
 
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Cybel

Involved In Discussions
#2
Hi, we have the same word "MINI" in the name of one of our products. For me, MINI is part of the tradename of the product under MDD and MDR, it is part of the device graphic logo and I've non translated it (but it is not included in the tradename registered with a national trademark office).
I've read you post recently and I came back now because I've just found the following here: Frequently Asked Questions (FAQ) – EU MDR

Schermata 2021-04-30 alle 12.13.10.png
For me, MINI in my device name is not used to identify the device more than if its name was XYZ.

Maybe I made it wrong, our application is currently under review of our NB and I'll discover it soon.
 

SANE

Starting to get Involved
#3
May I jump into this topic as well since I just face the same issue.

I followed the link to the MDCG but I still feel unsure what happens in the case once a wording is part of a trade name, not part of the trademark and if it is not internationally understood (so not as "mini"). For example the combined name for a device is "CytoALL Gewebefärbeset". This means it is also the product name to register it in the EUDAMED once possible. "Gewebefärbe Set" is typical German and not understood in many countries. So translation is needed. Once translated, will it require another registration as another product then?
As I see the registration base (EUDAMED) as described in MDCG papers shall offer three fields for translations, one for additional product descriptions in several languages but not for translated trade names.
I personally try to push CEOS not to take any words in local languages as part of the product names. But sometimes these products are already in the market and you have to take care of them to adapt all to the new regulations.

It would be great to get your input here as well which is so closely linked with the question of PVC Barbie`s and Cybel's post
 

chris1price

Trusted Information Resource
#4
I suggest looking at the second bullet of Annex I 23.2:

(b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;

So you could have the tradename as "CytoALL Gewebefärbeset" and not translate it, but you should then translate "Gewebefärb Set" to ensure the user can identify the device and its intended purpose.
 
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