Class I Medical Device GUI (Graphic User Interface) EU Translation Requirements

S

Shayanika

#1
Hi,

This regard to one of the medical device (Class I self certified) we are trying to sell in EU. Our medical device retrieves data from third party medical device and display it to the user. According to our EU representative the manufactures perform a risk assessment to determine if the software needs to be translated into EU language, also if there is no significant risk of misuse and or significant impact of the misuse related to the misunderstanding of the display, then we dont need to translate the GUI. I wanted to confirm if the interpretation is right.

Do we need to translate the GUI in EU language, even if our device is Class I

Thanks,
Shayanika
 
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M

Martin IT

#3
This is a quite controversial topic. The posts linked by Rob are very useful. In any case, my advice is reduce as possible the words and substitute them with symbols (e.g insted of 'language', you could use the flag of that language). Of course if the symbol used is not a worldwide recognised (but to be sure, I wouldn't make difference between recognised or not), in the user’s manual (it should be wrote in the language of the country where product is sold) you should explain the mining of every symbol used.
 
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