so, is vg a device?

So, EMA has sent an email to BSI saying they had a vote and the majority (??) voted that VG isn't a device. Although there has not been a "formal" response from EMA (how that happens I have no idea!)

So is it a device??

Here is the definition used by the EMA to classify whether or not something is a device:

Directive 2007/47/ec defines a medical device as (paraphrasing): Any instrument, apparatus, appliance, software, material or other article that is used alone or in combination, including software specifically for diagnostic or therapeutic purposes, that the manufacturer intends for use in human beings. Such devices are used for:
• Diagnosis, prevention, monitoring, treatment, or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap
• Investigation, replacement, or modification of the anatomy or of a physiological process
• Control of conception
This includes devices that do not achieve their principal intended action in or on the human body by pharmacological, immunological, or metabolic means—but may be assisted in their function by such means.


Obviously VG satisfies this definition in the following respects: It is a material used in combination for the use of alleviation of disease and treatment for an injury.

What determines whether a substance is a device or a drug (medicine) is the last part. Whether it achieves its intended action by pharmacological, immunological or metabolic means. In determining that we need to look at the substance in isolation from any "ancilliary medicinal substance" which may be attached to it. So, does the extra cellular matrix operate in any of the aforementioned ways??

Let's see:
pharmacology? - the science that deals with the origin, nature, chemistry, effects, and uses of drugs

No, the ECM is not a drug as it does not produce any sort of chemical change in the body

immunology? - the branch of biomedical science concerned with the response of the organism to antigenic challenge, the recognition of self and not self, and all the biological, serological, and physical chemical effects of immune phenomena.

No, the body's response to VG ECM is not an immune response. My understanding is that the body recognises the ECM as a part of the body's natural healing processes and simply builds upon it.

metabolism
1. The chemical processes occurring within a living cell or organism that are necessary for the maintenance of life. In metabolism some substances are broken down to yield energy for vital processes while other substances, necessary for life, are synthesized.
2. The processing of a specific substance within the living body

No, VG ECM does not provoke any breaking down of substances at a cellular level.

So using the EMA's own definition, VG seems to be a device rather than a medicine. Where does that leave us? I guess that either there will be an appeal and the EMA will discover its mistake or they will listen to the appeal and still say "no, its a medicine". option 1 probably leaves approval at least a year away and option 2 means more money, more trials and approval at least 2 years away.

A disappointing day for all!

Remember the CHMP are meeting again over the next 4 days and if there is to be an "official" response then it could come out of that meeting.

DYOR

Rev