Hi,

I agree with the above discussion . Design control is required for the EU release product .Actually DHF is used only before product release .Once the product is commercially released ,all changes are under production control and all changes must be documents in the DMR/technical file.

As per 21 CFR Part 820 DHF means compilation of the records which describe the design history of the finished device. But when compared to the ISO there is no specific requirements for Design history file, but how ever to market the product in US , manufacturer must comply with the FDA quality system regulations , which require DHF.

Both the FDA Design control and ISO design and development expect you to keep documentation and record throughout the product development process.