After listening to the lecture, it is clear that it is easier to get devices approved in the EU for several reasons. The EU bases their classification on an essential requirements checklist and on risk. In the United States, regulation by the FDA was created because products were harming people due to improper labeling. Thus, as per the FDA, testing on the medical devices is required to guarantee product safety for customers. While the FDA checks for effectiveness and safety, the EU classifies its medical devices on risk level. In the United States, the process of classifying a device is not as simple because the process involves a class system and it is not always easy to decide what the device belongs to. Medical devices have to go through processes such as the 510k, which is submitted by the medical device manufacturer for clearance, and also premarket approval prior to marketing. All of this involves clinical studies and the gathering of data in order to show efficacy. In the EU, a company is chosen to do testing on the devices, while the FDA is under the government. Thus, less data is required to prove how effective the device is. It seems like one can say that the regulatory side of the entire process in the EU is not as strict as the United States’ process. Overall, the FDA cares very much about efficacy and the EU cares about risk.