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

ernieto

Starting to get Involved
#1
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
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
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?
 

GStough

Staff member
Super Moderator
#4
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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