Ann: VitroGro ECM CE Mark Approval Referred to MH, page-32

re: Ann: VitroGro ECM CE Mark Approval Referr... 47 pages this one bt has a lot of definitions.


http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007504.pdf


I still can't find ( haven't got time at the minute )
"Annex IX of the Medical Devices Directive" as quite a few of teh PDF's refer to it but not sure it's relevance.


So what did they actually apply for? The comments that it doesn't affect TIS from his is just unbelievable or maybe he is referring to long long term.