Will it be on intact skin, on a mucosal membrane but not a route for fluids in or out of the body or in contact with a wound?
Is the device on healthy skin? Will it be in contact with breached or compromised skin like a wound? Or will it be in contact with a mucosal membrane? This can be an area of contention. Many products may appear to be mucosal membrane surface contacting products. But their function is deliver anesthesia or remove waste from the body. In this function, they are externally communicating devices.