"...how come "the lawyers" whoever they are,got this wrong?"It's...

"...how come "the lawyers" whoever they are,got this wrong?"

It's obviously not as clear cut in this instance as sh's would like it to be. Given it's gone from being a Rule 8 device (TIS/BSI) to Rule 13 device (MHRA) to not even a device at all(European Commission Medical Devices Group), we have to accept that the substance is in the uncomfortable legal grey zone. So much for those insisting last year it was obviously a Rule 8 device!!

Everyone probably has valid reasons to come to 3 different conclusions. In the end it can really only be decided categorically in a court, not just by individual lawyers.

Hopefully it won't come to that.