DMDIV-Variants : definition and technical documentation

[Agnès]

Dear experts,

what can we consider to be a "variant" of a DMDIV?
If same reagents are provided for 24RXNs in one box and for 48 RXNS in a second box, I would assume the 2 references can be considered as 2 variants of the same device and they will both belong to in the same technical documentation. Can someone confirm?

What about the situation where reagents are provided alone (box 1/ref 1) or along with controls (box 2/ref 2)? in that case, can we say the two references are two variants from the same device?

thanks

 

[chris1price]

Can you explain what you mean by DMDIV and which CE Marking regulation you are referring to?

 

[Agnès]

Apologies, I mean in vitro diagnostic medical device and I refer to IVDR ( regulation 2017/746).
thanks

 

[chris1price]

From what you are describing, this appears to be a packaging configuration change and not a change to the reagent or the controls. In which case you should be able to claim they have the same technical documentation, although the labelling will be slight different.

 

[Agnès]

thanks