change in medical device classication?, page-34

"Rev, that's just semantics and cheap. It doesnt change my fundamental point. Rule 8 devices go to Class III and rule 15 devices go into class IV. My point is that they should have gone for the higher classification where there was obvious doubt which of the 2 rules applied. So what is your point?"

My point is you are wrong again because you don't seem to do any research.

Rule 8 can classify a device into Class IIa, IIb or III and in VG case would most likely have put it into Class III.

Rule 13 classifies all devices as Class III.

Neither Rule is a higher classification, they are simply formulas for deciding how to classify a device. Either rule would have led to the same conclusion and neither strictly fit with Vitrogro.

And TIS doesn't "go for" a higher classification. It depends on the notified body, BSI, to use the rules of the annex to classify the product into the correct class.

Rev