Confirming compliance with regulatory requirements and approving the product to be traded in the EU does not add value to the manufacturer?
I didn't say it doesn't add value, just that adding value is not the purpose. The purpose is to verify a certain minimum. Apparently having such minimum verified represents added value as compared with not having that minimum verified, but since "adding value" (in the general sense) is not the driver but rather the result the process runs out of fuel as soon as the minimum is verified.
In the specific context of clinical evaluation it is apparently simpler and easier for the NB to verify regulatory compliance through compliance with the
MEDDEV, than through any other method, so there's no drive on their part to "have a dialogue" or to add value beyond the bare regulatory minimum. At most they would provide clarification, and I would venture a guess that it would go along the lines of MEDDEV being state of the art and so on and so forth.