purchasing vitro gro for use in australia??, page-8

I dont think that the question is whether this is a device or not.
see part of ann.


Biomedical company, Tissue Therapies Limited (ASX: TIS) has been advised by the EU Notified Body,
the British Standards Institute (BSI) that the CE Mark application for VitroGro® ECM has been referred
to the UK Government Health Regulatory Body, the Medicines and Healthcare products Regulatory
Agency (MHRA) for a final decision as to which Medical Device Directive Rule is appropriate for the
classification of VitroGro® ECM; Device Rule 8 or Device Rule 13.