Marking "Distributed By" to product with distributors' reference-code

#1
Hi to all, this is my first message to forum, and it may be little silly and simple, but with regulatory issues, better safe than sorry.

Company I work for distributes a CE-marked medical device to EU market and now we would like to mark this device with our reference-code and information.

Manufacturer is within EU and my company is also.

So the thing is that we are selling this medical device with our own reference-code to the market, and therefore want to attach label stating the reference-code and our information. Original label that states manufacturer and model-name with CE-marking would still be visible, we would just attach our label next to it.

So the plan is to attach label stating "Distributed by" (or distributor -symbol included in the upcoming ISO 15223:2020) + our name and contact-info and our reference-code "Distributor reference XXXXXXXXX".

My concern is that does this make us manufacturer in the eyes of MDR Article 16?

My understanding is that "Distributed by" -labeling is common, but does the fact that we are giving the product our own reference-code make the distributor the manufacturer?
 
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Awadine

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#3
Hi

my take is that providing you are only adding to the outer packaging, are not obscuring the manufacturer’s label and the manufacturers ref and details are clearly visible then this would be acceptable and you are not at risk of being considered to be the legal manufacturer.
 
#4
Thank you Awadine for your comment. We took an approach to mark devices as described in the first post, but felt the need for ask the manufacturer permission to do so beforehand.
 
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