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.
Thanks
Tanja
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.
Thanks
Tanja
