ce mark, wounds and recombinant proteins

Wound healing is a huge market and Vitrogro obviously isn't the only product in the space.

In Dec 2012, an Israeli company received a CE Mark in Europe for VergenixWD, a recombinant protein-based wound dressing. This is a human collagen scaffold derived from genetically engineered tobacco leaves.

Vitrogro is a recombinant protein-based wound healing substance not dissimilar to the functionality of VergenixWD (in principle anyway). Yet just 3 mths after VergenixWD was given its CE mark, Vitrogro is considered ineligible as a medical device by an EC working party.

If VergenixWD is eligible, Vitrogro is eligible. If Vitrogro is a medicine, VergenixWD is also a medicine.

Interesting that Collplant has a CE mark application in for another recombinant protein wound healing substance - VergenixFG. I wonder whether they're getting the same run around.

I also wonder whether VergenixWD was approved under Rule 8 or Rule 13. MHRA would know. They have access to the European Databank on Medical Devices (EUDAMED), and MHRA say Rule 13.

Was VergenixWD submitted to the EMA in the same way Vitrogro has been?

EU bureaucracy at its best! I'm sure TIS is pointing these legal discrepancies out to the CHMP.