I do my best to be charitable about the limitations of a standards creation process that is implemented by real people, but to my thinking, the current state of Annex ZA is pretty inadequate as a work product.
"Content Deviations", item 3(b) says that the MDD requires "risks to be reduced 'as far as possible' without there being room for economic considerations."
Except that's not what the MDD says.
Annex I Section 2, for instance, requires that device designs "must conform to safety principles" (which thereafter are enumerated, beginning with "eliminate or reduce risks as far as possible"), but conditions this requirement by going on to state "taking account of the generally acknowledged state of the art."
When I went to engineering school, we were taught that the "state of the art" in science was what is physically and chemically possible...a purely theoretical definition...but that the "state of the art" in engineering additionally requires determination of functional optimality and economical feasibility as judged by the organization to which the engineer is responsible. I doubt very much if well taught engineering students learned otherwise a hundred years before me, and I'm pretty confident that engineering students still learn that today.
Scientists create theoretical understanding. Engineers create real products and services...including medical devices. I've yet to hear of a medical device company or a national health system that isn't affected by economics.
So how did the committee that settled on the wording of Annex ZA arrive at "...without there being room for economic considerations"?
If the author of those words worked for me and presented that as a draft, we would have had a little talk about reading comprehension and how much medical care could be provided in a cost-no-object system, and they would have gone back to do it again.