Dear all,
I am tasked to find out what kind of label changes (EU-MDR confirming label) would lead to a change notification in Russia and how to address it.
Unfortunately, I do not know the changes to the label. I would presume, that for example a change in the device description in a language not mandatory for Russia would not cause any issues? On the other hand, a change of symbols or information regarding e.g. precautions, storage, etc. would lead to a change assessment in Russia?
Is there a GOST-procedure to follow with such changes?
Thanks a lot for your help!
Kind regards :-)
Britta
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Britta Cyron
Regulatory Affairs Manager
Dortmund
Germany
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