re: Ann: VitroGro ECM CE Mark Approval Referr... No sure there...

re: Ann: VitroGro ECM CE Mark Approval Referr... No sure there really is strong support at 35 as this if it goes bad is a game changer and support evaporates when it comes time for a raising. Just hope the bots don't push this down for the benefit of SI trying to get a bargain.

Always 2 strategies with these be it wait to see if approval comes and if there is any momentum from sales ( always happens slower than people price in) or get in early and ride it out always leaving enough in the kitty if it dips and have teh huge risks. Not easy.


I don't think think is as simple as management is making out depending on what path they have originally chosen.

Management is glossing over a magor screw up here that has huge affects on TIS , its financial position and calls into question their ability to manage the whole process. Can't imagine the partner is very happy.

"If more than one rule applies to a device, the highest classification stands"

Did they try for a lower easier classification and get caught out?
What classification do similar products have ?


Look at the aims of the rules. Look at the CE site.

Wonder what part of documements TIS thought didn't apply and if they tried a shortcut and if they actually were fully prepared for this.

What is teh parallel position with the FDA? Extra expense trials qualification and validation?


http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevicesDirective/Classification/index.htm

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007492.pdf

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007495.pdf

http://www.ce-marking.org/directive-9342eec-medical-devices.html