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  • Fady Khalla replied to the topic DHF vs. Tech File/Design Dossier in the forum The Design History File 8 years, 8 months ago

    The DHF and Technical file are different documents that have the same content. The Technical File is a snapshot in time of the design without giving much consideration to the design history or the mistakes that were corrected along the way. In my opinion, the EU regulation was built in a way to guarantee that the design is safe and effective in its current form without much consideration to older versions. In their prospective, it is perfectly okay if after 10 design changes the design was modified to become in its original form again as long as the device in its current form is safe and effective for its intended use. I have also seen notified bodies that ask for change control history for a certain design and ask for supporting older version documents.

    On the other hand, the FDA believes that the whole design history should be available to prevent such situations. It is believed that a whole DHF will give the design team the required information to avoid mistakes that occurred in older versions. I see the benefit of having both in place, especially that the Technical file is just a snapshot in time from the DHF. So If you have build your DHF properly, you can definetly have a technical file.