The last post here is the most accurate. Design Controls are not “needed” in the EU in the sense that they are not mandated by a regulatory body like they are in the US. Granted, it is still a good idea to use something like Design Controls as a coherent design process to catch errors before the product is launched, but it is not mandated.

Like the post above suggests, EU regulatory looks a device development as a snapshot in time in the Design Dossier or Tech File (depending on device class). A DHF looks at the whole complete design process from beginning to end and tracks the rationale at each step.

How would you compare these two philosophies? What are their pros and cons?