NZ company - tissue repair product, page-23

What I am saying Tim is that you HAVE misinterpreted the process flow. This is directly from your quote:

"It is for the manufacturer to initially determine the classification of their product(s). This will allow them to select a notified body (if required) with the ability to carry out the appropriate conformity assessment procedure. It will then be for that notified body to confirm the classification arrived at by the manufacturer before embarking upon the process of conformity assessment."

Note; "It will then be for that notified body to confirm the classification arrived at by the manufacturer". This is in line with the responsibilities of a standard organisation. You have answered your own misgivings by openly stating that IT IS FOR THAT NOTIFIED BODY TO CONFIRM THE CLASSIFICATION ARRIVED AT BY THE MANUFACTURER. Hence, TIS acted on that advice - again, as they are not a standard org, what are they supposed to do? Go against that advice? Surely you are not suggesting that TIS was advised to lodge under 13 but went 8 anyway? This didnt happen but that is a fairly stupid thing to do. If they were advised to lodge against 13, they would have.