Here is the situation: the notified body has been appropriately informed of a potentially significant change to a device, and has responded that because of their workload they cannot give even an estimate of when they will review the notification. we would prefer that they review and approve the change, but because of the switch of emphasis from MDD to MDR, the notified body is overwhelmed. This puts the company into a grey area. any recommendations for actions we can take? how long is a reasonable period to wait for a notified body response before going ahead with business plans that involve the device change?