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cef3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 10 years ago
It seems that the DHF is superior to the Design Dossier or Tech File in it’s thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead.
From the same link that pt58 posted: “Newer EU regulatory guidance documents are moving the TF/DD more in the direction of the DHF. However, a review of both descriptions above shows much commonality already, allowing the development of both files (DHF and TF/DD) almost concurrently, while supplementing the DHF with the DMR for a current TF/DD.”