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?
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?