Thank you Rob 73,
I know that we don't have to do it, and I can certainly justify via risk assessment the reason why, but I'm wondering whether if the device is not uniquely identified a system should be in place to ensure that it can be traced. For example, the device is put into use in a hospital that is full of previously ordered devices that they have purchased from us before, and nobody records the serial number from the packaging and assigns it to it's location. A few weeks later we discover that there is a manufacturing fault associated with a certain batch of raw material in our product, and need to recall the affected devices. On contacting the hospital that has received one of the affected devices, how can they identify it amongst all the others? Is it just enough to accept the fact that all devices must be returned? Is the onus on the customer to have a system of traceability at their facility, or us as the manufacturer to inform them to do so?
Jo