Design Controls are not needed in the EU regulations, because they view a “snapshot” of that given point in time of the life of the device, they are searching for issues that could be present. The Technical File and Design Dossier is equivalent to the US’s DMR, it looks at the product’s development process. It is not required in the EU to include a DHF but a company can still implement it. In terms of which is best, i believe it is a good idea to include the DHF for the EU, this is because it keeps track of all design processes, and this can be helpful when attempting to review old decisions of the product’s design once it has been passed along to production. It serves a way for the company to learn from their mistakes and view where along the design process decisions were made; this allows companies to search for a solution. The Tech File and Design Dossier already includes a design control procedure so by including a DHF, it wouldn’t hurt the company but make it easier in the future. As another user mentioned before, Information is best written to reference them, information cannot live in the mind of the creator because it can be forgotten and lost. The limitation for the DHF would be that it is a frozen file and cannot be edited, that is what the DMR is for (Live document), but the DHF has it’s importance for the design process.