Device, medicine ? Absolute cock up by everyone. Congratulations to TIS for not being aware. Extra cudos to BSI for not knowing or advising TIS, and extra big thanks to those totally hopeless eurotrash bureaucracies that exist primarily to hinder and fleece everyone and everything around them. Good grief! I wonder who or what advised the EC medical devices group that the classification should be reconsidered. I would assume TIS would be pressing for a detailed factual explaination as to why the "device" is now a medicine? My position is still hold but HC doesn't have a sentiment called shit.
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