TDA, if I believe I am right, why should I not talk as if I believe it? If however, perchance I realise I am wrong on something or someone corrects me, I will be the first to admit it. I think that's called being honest. It is also one of teh best ways of learning: formulate a view, propound it, listen to criticisim and if criticism is valid modify the view. Socratic dialogue. Wooses who never have a view and express it, or who then hold to a view when it is wrong are a waste of space.
My main premise was that TIS proceeded with VG under rule 8 dealing with inplantable devices, rather than under rule 13 dealing with devices incoporating a medicinal substance. Each rule (with some exceptions) puts the device into a separate class. The process for CE mark is different for each class. Whether you want to call "medicinal" devices as being in a "higher" or "lower" class is irrelevant. Nonetheless, it is obvious that a device that has medicinal operation is going to be held to higher standards than those that do not. We are now going to the EMA for that very reason.
TIS Price at posting:
37.0¢ Sentiment: Hold Disclosure: Held
