Language requirement DoC

#1
Hi everyone,

Concerning the obligation to translate the DoC to the language that the member state requires
Art. 19 (1) "The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.

Has anyone found any clear information concerning this from each member state? I have tried to navigate in different member states web sites ect. but cant find any clear information. I read this guidance from Medtech Europe - "Language implications of MDR for labelling of Medical Devices (MD)" (cant post the link)

Which states that only Czech Republic requires the DoC to be translated in Czeck, otherwise English (or any other official language) will be ok.

Someone else has any other information?

Thank you for your help!
 
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#4
DoC shall be translated into an official language required by the Member State IN WHICH the device is made available.
Schermata 2021-05-07 alle 17.10.33.png
English is official language only in Ireland, Malta (and UK). Other countries have their own official language(s).
Translation of DoC in each language of each country were I foresee to sell my devices is part of the list of documents required by my NB for MDR application.
 
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