7.5.3.1 Identification The manufacturer shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification. The manufacturer shall establish documented procedures to ensure that medical devices and in vitro diagnostic medical devices returned to the manufacturer are identified and distinguished from conforming product. 7.5.3.2 Traceability 7.5.3.2.1 General The manufacturer shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required. Where traceability is a requirement, the manufacturer shall control and record the unique identification of the product.