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I am working on requirements on labeling (both device and packaging) within the European Union (and outside). In an article I read that, when you export within the european union, the labeling has to be in the language you are exporting to. Our products have CE marks but until now the labeling has always been in English and I am wondering whether we have to change this when we are exporting to a non-English speaking country. Or can we suffice with the instructions-for-use being in the language of the country and leave the labeling in English?
Furthermore I am wondering whether there is an official reference on this topic. The Medical Device Directive (93/42/EEC) is not very clear on the language topic and the only other references I have found is not “official”. The pdf article that I found: Medical Devices in the new EU
Hope you can help me
Furthermore I am wondering whether there is an official reference on this topic. The Medical Device Directive (93/42/EEC) is not very clear on the language topic and the only other references I have found is not “official”. The pdf article that I found: Medical Devices in the new EU
Hope you can help me