Quality Digest

Dear all,

I have just started working in the field of ce-marking and I have a question
I can't seem to get an answer on.

I am working on requirements on labeling 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 url of the article that I found:

http://www.ce-mark.com/neweu.pdf

Hope you can help me.

Thank you in advance,

Kind regards,

M.Hultermans

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