The problem is really more weird, and, as i've said somewhere else before, even the EU is not really sure of their own arguments (I was with the guy responsible for the formal Eu answer to this problem and he even he wasn't aware what was really happening
)
One example - in New Approach directives, directives have essential (less detailed) requirements, and harmonized standards details that essentials requirements and therefore gives 'presumption of conformity' with the essential requirements they are linked with (annex zx). However, this presumption of conformity is only related to the essential requirements which are given in annex I of the directives. Quality system requirements are not in Annex I, they are only required in the "route" annexes (particularly the annex II route - full quality assurance). So, one of the problems is that ISO 13485 cannot really give presumption of conformity.
Yes, Kim Trautman is a WG 1 member and represents the FDA. From the standpoint of the standard, she didn't seem to have any problems (she mentioned the VARSP program but only to remember that she would prefer the standard to stick to requirements which were already on the regulations) but nothing regarding the EU. As i said, the focus of the discussion obviously was the standard, not the regulations that use them, because it was deemed that a lot of the comments were really problems of the regulations, not the standard.
Update: Just to make things clear here, i didn't imply i know Kim's or FDA's position, what i said is only what I felt during the meeting.
