CE-IVD mark on packaging

Tanja S

Hi Everyone,

I would appreciate your help with this. We are looking to use already CE-IVD marked blood collection tubes but in our own packaging. Do we need to clear the entire kit that we will have for CE-IVD mark or is just using the CE-IVD medical device enough? I was under the impression that it all has to be cleared and the CE-IVD mark to be put on the outer packaging as well for it to be considered CE-IVD marked.

Please help as my colleague is saying different.
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