Class III Kit Box - Are translations mandatory under EU MDR?

kunal9218

Starting to get Involved
#1
Hi,
I have a question: Are translations mandatory under EU MDR? I am working on a Class III device and the product team does not want translations of the device name under different languages.
Thank you!
 
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dgrainger

Trusted Information Resource
#2
It has to be in in the official Community language or languages of the Member State.

"Article 10 - General obligations of manufacturers:
11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient."
 
Last edited:

monoj mon

Involved In Discussions
#4
I agree with Raisin picker's comment! We usually don't translate the "Device Trade Name", rather we keep it in English. We then translate the rest of the sections such as Instructions for use, contraindications, etc. into different languages in the IFU.
 
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