No law determines responsibility.
No. The law is law.
How can you post such .................?
No business agreement can override any law.
Nobody can be absolved from legal responsibility by any business agreement.
I'll try to clarify.
I'm sure we agree that every medical device has one party with primary regulatory responsibility.
Scenario A: I manufacture a device myself, I properly apply my CE Mark to it, and I market it. I'm regulatorily responsible for it.
Scenario B: I contract with another company (a "contract manufacturer") to physically make a device for me, then I properly apply my CE Mark to it (or have the contract manufacturer apply my Mark for me, or provide me with labels containing my Mark that I will apply), and I market it. I'm regulatorily responsible for it.
Scenario C: Like Scenario B, but the company that physically makes the device also separately markets it under their own name, with their own CE Mark.
Scenario D: The company that physically makes the device applies their CE Mark. I buy the device from them and market it as a distributor...that is, it remains labeled with their CE Mark and with them identified as the regulatorily responsible manufacturer.
My understanding of medicalcomp's posts earlier in the thread is that they originally thought that their business arrangement with their customer was Scenario D. Either the customer changed their mind, or there wasn't a meeting of the minds in the first place, and now the customer wants to proceed according to Scenario B.
My point was that in any medical device dealing, it should be clear that both parties have the same understanding of which scenario applies. None of the major medical device regulatory systems...the EC's or the US or Canadian systems...prevent such confusion as a matter of law, though they have elements that attempt to govern what happens if things go wrong. To avoid the applicability of those rules, it makes sense for the parties involved in any such relationship to have an agreement that they identically understand.