MDR Labelling & Languages

#1
Hello,
I work for a medical device company that manufactures personal lubricants.
My query relates to the approach to take with regard to languages and labelling under the MDR. Our products are provided in tubes varying in size from 40-150ml which are placed in a carton with an IFU for sale. We sell into all EU countries and our IFU contains 27 languages to cover this, however under the MDR it states the 'label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold'.
On the face of it this seems to say that if we sell into all EU countries our cartons should also display information in 27 languages which is not going to be possible due to the carton size (we use symbols to convey as much information as possible). I would love to know if others are facing this issue and what solutions they may be using
 
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#2
Is your carton a sale packaging?

In our company, we package the devices depending on the destination country (for example: Poland), so we put a label in that language only (Polish). Or, possibly, we create groups of languages (for example, we have a label including Danish, Swedish, Finnish for the Scandinavian market).
The same is for IFUs.
This system has pros and cons, for example we can avoid to include 27 languages in the user manual, but of course this means we cannot have a big stock of packaged units in the warehouse...in our case it is possible, but of course it isn't to everyone...
We also have a "standard" packaging (including English, Spanish, French, German) that applies to the most frequent orders, so we can have a "standard" stock useful in most cases.
 
#3
Yes our carton is our sales packaging.
Due to our business model (we sell both direct to customers across the EU via a website as well as to Trade customers who then sell on within the EU) separate packaging with different languages to meet different country requirements wouldn't really be feasible. This is such a headache for us, we are really struggling to find a path that will work!
 
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