IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC

D

dchinny

Registered
#1
#1
Dear Community
Is it correct that:
> All components/accessories within an IVD (98/79/EC) Kit require CE mark in their own right?
> and that as soon as the OEM device (component) is re-labelled, the re-labeller/packer then take responsibility of the product and becomes the legal manufacturer
> does this then mean that the re-labeller/packer needs to develop separate Technical Files for each device and/or have in place a written agreement with the OEM for access to TF
> and that the re-labeller must assign a UDI to each component
> finally, is possible that while the final assembled system will contain individual CE marked devices, the assembled kit itself will not need to carry the CE

Thank you for your input
 
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chris1price

chris1price

Trusted Information Resource
#2
#2
I am sure there are different ways of doing this, but in my experience, the reagent, controls and calibrators (as appropriate to the product) will all have separate entries on the DoC, so separate CE Marks and also separate UDIs. The complete kit, ie a pack made up of all the components, would not have a CE Mark.

I can't comment on the relabeler/packer, This may vary on agreement you have with them.
 
D

dchinny

Registered
#3
#3
Thanks Chris, that's pretty much as I thought. A company has asked for some input for a product they are just about to go to market with before I flagged up the supply chain and labelling issues. thanks for being my bouncing board on this one
 
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