the irony of the simplicity of vitrogro

It seems to me to be ironic that the approval of Vitrogro, along with all the benefits that will eventually be realised by ulcer sufferers everywhere, has been caused by the fact that it is applied simply in a non-surgical setting.

According to Rule 8 if Vitrogro was an "implantable device" or a "surgically invasive device", both of which require a surgical operation, then we would have approval by now because Vitrogro would fit into a nice little legal (bureaucratic) definition.

Unfortunately Vitrogro is much simpler than that. You just squeeze it on the affected area and off you go. Who would have thought that making something so easy to apply would have people standing around scratching their heads over what to call it.

I suggest the next move of TIS is to update the Vitrogro user guide to ensure that patients undergo a day procedure involving a 1mm long and .5mm deep incision by scalpel before application of Vitrogro. This will tick the surgical intervention box and Rule 8 will be applicable.

Kidding,

Rev

Here are the relevant definitions:

2.4. Rule 8
All implantable devices and long-term surgically invasive devices are in
Class IIb unless they are intended:
— to be placed in the teeth, in which case they are in Class IIa,
— to be used in direct contact with the heart, the central circulatory system
or the central nervous system, in which case they are in Class III,
— to have a biological effect or to be wholly or mainly absorbed, in which
case they are in Class III,
— or to undergo chemical change in the body, except if the devices are
placed in the teeth, or to administer medicines, in which case they are in
Class III.

Surgically invasive device:

An invasive device which penetrates inside the body through the surface of
the body, with the aid or in the context of a surgical operation.
For the purposes of this Directive devices other than those referred to in the
previous subparagraph and which produce penetration other than through
an established body orifice, shall be treated as surgically invasive devices.

Implantable device:

Any device which is intended:
— to be totally introduced into the human body or,
— to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the
procedure.
Any device intended to be partially introduced into the human body
through surgical intervention and intended to remain in place after the
procedure for at least 30 days is also considered an implantable device.