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.
TIS Price at posting:
40.0¢ Sentiment: Hold Disclosure: Held