classification of vg

Why are we at this point? Here are my thoughts and research re classification:

Annex IX is what is used to classify a device.

Refer: http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf

It has pretty clear rules and pretty clear definitions. Reading through it VG comes under the definition of an invasive device which is used long term. I can’t see how it can be read in any other way! It is not a surgically invasive device! It is not an implantable device because implantable devices are implanted by “surgical intervention”. VG is not! Therefore Rule 8 is not applicable. However, if Rule 8 was applicable then VG would be classified under this rule as Class III.

So if it’s not Rule 8 then the only other Rule which comes close is Rule 13. Rule 13 is only applicable if VG incorporates a medicinal product and that is defined here:

http://www.coe.int/t/dghl/standardsetting/medicrime/dir2001_83_cons_20081230_en.pdf

At this point I am unable to say whether it fits into Rule 13 or not as I don’t know whether VG incorporates anything which is defined to have a pharmacological, immunological or metabolic action. I’d say no to immunological but don’t know about the other 2. However let’s assume for a moment it does have such an action. If so then Rule 13 is applicable and VG is classified as a Class III device. So regardless of the Rule which is used (8 or 13) VG would still be Class III.

If Rule 13 is not applicable then VG does not fit into any of the device rules. I can hear some people now saying “ah hah. I knew it. VG is not even a device”. Having read through the literature so far I don’t believe that to be the case. I simply think VG may not fit into any of the little boxes which have so far been created regarding devices. I think that may be why there is a certain amount of head scratching at this point.

Anyway, what is more important than device classification rules is the actual classification which is arrived at. Given rule 8 and rule 13 would both have led to Class III then let’ assume that was the class decided upon by TIS and BSI. This is the Regulatory process for devices:

http://www.emergogroup.com/files/medical-device-regulatory-process-europe.pdf

The only thing different about Class III products is that the manufacturer must prepare a Design Document. Let’s hope this was done (I’m sure it was).

So what’s the hold up?? My guess is VG doesn’t fit into Rule 8 or Rule 13 (or any other rule) so the usual classification guidelines don’t work. They therefore had to refer the matter to the governing body for a ruling. How long will that take? Who knows? Should the issue have been picked up earlier? Yes but maybe it was already known and someone dropped the ball by waiting until now to do anything about it. Who is responsible? My guess is BSI because they could have consulted with the governing body early about this point rather than conduct their audit and then try and work out how the product fits in with the Rules.

Sorry for the long post but I found all this info really interesting. It answers some questions and I’m sure others out there are equally interested.

Rev