change in medical device classication?, page-28

"Unquestionably, this is a boad and management stuff-up. Even if they had advice that VG was a non-medical device under rule 8, it is plainly obvious to even me as a layman that there was considerable room for conjecture that it was in fact a medical device under rule 13. Why would any sensible reasonable person use a lower classification which was potentially in doubt when you could easily use the higher classification and avoid almost 12 months of delay? I mean you dont need advisors to tell you this sort of stuff. It is basic common sense. In my view there has been a failure to act with due diligence on the part of the board and management."

Resourced, the above post is nonsense. You admit to being a layman but put forward an uninformed opinion as though you are an expert. Rule 8 and Rule 13 are NOT CLASSIFICATIONS!!! They are rules used in Annex IX to determine the correct classification for a device. How about you read my other posts and more importantly read annex IX and other references I have cited on this forum.

Rev