I would agree that the DHF is considered a living document due to its importance in holding all the required information during the design controls. However, after the design transfer process is completed, the DHF should be utilized as a reference document to demonstrate the required production specifications. Some of these include how to test the device for safety and efficacy and still check with the various verification and validation steps. At the completion of the design transfer it denotes the line where implementation starts and anything that required changes were all done and concluded within the design controls. Also, it also assists in maintaining a quality and consistent product during the manufacturing and launch phase.

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