DOC Translation

MDRexpert

Involved In Discussions
Hi Everyone,

Does the DOC need to translate all the standards included in them as well?

Thanks,
Akanksha
 

RA_QA_Expert

Involved In Discussions
Hi, we are experienced that it is required by customers, the solution can be to use number of standard only without names.

If you use also reference to any Directive, it should be includes also reference to natioal transposition of the Directive of the member state you are located or your AR is located. This is not valid for Regulations.

Just to add, EU DoC should be in the language required by local member state law, i.e. in Germany it is German, in France it is French and e.g. in Czech Republic it is Czech, Slovak and English, etc.
 
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