Putting AR's name and address on label - Authorized Representative Labeling Requirements

mpfizer

Involved In Discussions
#1
Hi,
I have the following questions on putting the AR's name and address on label
We are a manufacturer based out of EU manufacturing class 1 and 11 a 11b products
Some of our products are self certified and we just put CE logo on the other products we put CE logo along with NB number.

As per MDD & MDR what are mandatory requirements on label as far as AR details are concerned

For self certified and certified products ( with NB number )?

Do all above products need AR details even if not sold in EU but marked with CE logo or CE logo with NB number?

Thanks

michelle
 
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