I think the EMA just struggle with the whole concept of a device being something that comes in an ointment form containing a microscopic lattice. Surely a device is something big that you can hold on to. I wonder looking into the future what they will make of a nanobot the size of a red blood cell being injected into the blood stream and programmed to work on damaged tissue. A device?? Surely not!
Rev
In search of a clear path - now is the time to act, page-6
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