Saturday, February 20, 2021 6:25:06 PM
Setting aside the back-ground for a moment, is it possible that they have the answer to dealing with this mess?
Extremely unlikely!
I really don't see how they would get a 'medical device' CE certification.
Every genuine CE mark for a medical device has a 4 digit number which points to the notified body. The notified body website will then have the details of the product and the associated regulatory filings including test data etc.
Without that 4 digit number, the trail is cold, and the claims are hot air!
Look... even leaving aside for 1 moment the complete LACK of actual TEST DATA, I am looking at that stupid strip port insert connector thing and thinking there is probably NO WAY that thing ever even passes the ESD requirements, (even if the glucose meter itself did!) for any CE mark, let along and IVD one!
To say nothing of the fact that it has sharp edges that you could cut yourself on! IVD devices are supposed to be SAFE! Its a basic requirement!
Part of me was wondering if Berman or his chums could have got some sort of CE mark on it but NOT as an IVD medical device? There are other categories of CE marking than IVD.
e.g if they classified it as 'a toy'? (But I doubt even that... the sharp edges on that stupid POS insert would probably preclude even that tbh!)
https://en.wikipedia.org/wiki/CE_marking?
No. See this for what it is!
Its just more Berman-esque gaslighting.
The more I think about this, the more apparent that becomes!
