The quality of a product does not necessarily depend on how many regulatory rules there are. One can require hundreds of rules on a device yet produce a very low quality product. I believe that the steps and precautions taken during production of a device is the ruling factor in if it is of high quality or not.

With the EU having less rules, the manufacturing of the device is more prone to mistakes than if there were more regulatory rules. For example, say we are producing the same medical device in the US and the EU. We are manufacturing a device where all the products are purchased from Home Depot and ACE Hardware. But after some research, we realize that Lowe’s provides all the materials needed and we start purchasing materials from this one store. This change in supplier would be recorded in the DMR in the US but not in the EU. This notation in change of supplier keeps the company updated and ready to find a new supplier: in case Lowe’s were to go out of business, they can always revert back to purchasing their materials from Home Depot and ACE Hardware. But this information would not be readily available in the EU and would be more of a hassle to find a new supplier since nothing was written down.