IVD Vials - If we CE Mark a kit's package, do we also have to CE Mark the vials?


Starting to get Involved
Question: if you CE mark the kit's package, do you also have to CE mark the vials? Not clear what is the rule here. Thanks in advance

Ronen E

Problem Solver
Is the kit an IVD MD? Does it come under the IVDD or under the MDD?

What are the kit's components, other than vials?


Super Moderator
Also, what size are the vials? If they are too small for the CE Mark to be applied, there may be an exception in that case.
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