MDD Article 12/ MDr Article 22 interpretation

UNIJP

Starting to get Involved
#1
Hi.

I have a question for y'all about the system/procedure pack compliance.
We are manufacturing a pack that went through conformity assessment under article 11.

The question is, if I want to swap one of the components, which manufactured by us, to another component, which is manufactured by a different manufacturer and bear CE marking of them, can this be placed on marked as procedure pack based on MDD Article 12/MDR Artcile 22, given that intended use and functionality doesn't change?
 
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chris1price

Trusted Information Resource
#2
Without this component, is your device CE Marked? To use Article 12, both products must each, separately, carry a CE Mark. If that's the case, you can do it under Article 12.

If your product is not CE Marked without it, then you have to go through Article 11. From your description, this appears to be case.
 

UNIJP

Starting to get Involved
#3
Without this component, is your device CE Marked? To use Article 12, both products must each, separately, carry a CE Mark. If that's the case, you can do it under Article 12.

If your product is not CE Marked without it, then you have to go through Article 11. From your description, this appears to be case.
Thanks chris1price for your comment. Currently the product is not CE marked without it, looks like Article 11 applies. However configuration without the component should be able to fall into the same CE certification. It sound like a loophole but Article 12 could apply in this case.
 
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