First the good news. VG has now been classified as a DEVICE in Europe!!! This is actually news folks because up until now there was an outside chance it could have been refused device classification and we would have to embark upon a whole new range of trials causing delays far longer than we are now seeing.
Secondly I understand the anger and frustration of some here and I too am disappointed we have to wait longer before going to market. But I really think that directing our anger at management is misplaced.
For those of you who are getting bogged down second guessing what rule we should have been seeking, you are barking up the wrong tree. As I have stated before, it is my belief that VG does not strictly fit in with any of the rules in Annex IX. It was BSI, not TIS, who had the responsibility to find the rule with the best fit to try and classify VG. It is the classification which is the point we should focus on and Class III was always a possibility if not a probability. TIS catered for this possibility when it conducted its trials and that is why they haven’t been asked to now conduct further trials for a Class III device.
My thoughs only,
Rev
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