Hi, we're developing a Class I medical device, it will be used by only physicians. Our device is of size to be fit in a palm. It's a mobile device to be carried on the physician. Do we have to put the device label on it? For design considerations, we do not want to put all the symbols, the name of the manufacturer and the long address on this device. Is it enough to just put the CE mark and some important symbols on the device and leave the rest to the box label or user manual? Or can we put this info like the manufacturer, address, manufacturing date, device ID, etc. somewhere inside the device?
I could find specific info or clue for the placement of the label in MDD or guidance documents. I would appreciate your help.
I could find specific info or clue for the placement of the label in MDD or guidance documents. I would appreciate your help.