I don't think there is an NCR here - at least from the information provided.
However..........
The label copy must be in at least one (Member State) language according to the Directive. (Article 4.4)
4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
Whilst the Directive is "only" a magazine article, it is the transposed law in each country that applies. However there is already precedent that CE marked devices that are not intended to be sold in Europe (yes it happens) must still have at least one Member State language, and must also have a European address / Authorised Representative.
Translations tend to be done by the manufacturer, or the distributor, or as a joint exercise.
In my opinion, translation is a manufacturing step (arguably a design step also), and thus must be controlled under Clause 7. If that activity is contracted out (i.e. to distributors) it must still be controlled.
After all, it is still the manufacturer's name on the box, it is still their CE-marked product. The manufacturer STILL bears responsibility.
There is of course of particular concern where the IFUs are complex and the distributors have (not unreasonably) a speciality in sales, rather than clinical matters or even language skills.
It is also important, even for low-risk devices, where the products are intended for home use.
I have raised NCRs where the English text filled one side, and there were 5 languages on the back. It didn't really matter whether or not I could personally understand those languages, it was obviously an inappropriate translation, perhaps even posing a safety risk.
Finally you can't raise NCRs against NB-MEDs or MEDDEVs
per se. Note however that MEDDEVs are official guidance and should be followed unless a strong justification exists.
(The arguments I hear for not complying with the contained guidance tend to be pitiful. An NCR against either the MDD or ISO13485 usually follows in short order.

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