Introduction Every year millions of patients flock in the American and the European healthcare facilities to seek for healthcare services. Both Europe and the US have their distinct regulations that govern the sale and use of drugs and medical devices. In the US, the Food and Drug Administration (FDA) is the body responsible for approving both the medicines and the medical devices (Basu and Hassenplug 485). In Europe, medical device approval is the mandate of the Competent Authorities and the Notified bodies while drugs are approved by other agencies that will be discussed in this paper. There have been claims that the US regulatory system is slow, inefficient and expensive compared to that of Europe. Skeptics of the US system cite the fact that European patients get access to high-risk devices before their US counterparts. For example, the American medical device regulatory system emphasizes efficiency checks while the European system only requires proof that the device is performing as expected. The strict procedures under the US system cause delays in approval denying patients access to certain high-risk devices in time. This paper shall compare and contrast the two countries’ regulatory systems in light of the drugs and medical devices approval. Approval of medical devices Similarities One of the notable similarities between the two systems is that they are both designed to stimulate innovation. The European regulatory systems were established to encourage innovation to improve the quality of services in the European healthcare facilities (Curfman and Redberg 975). The US system also encourages innovation by allowing the efficient devices into the healthcare market. Under the US system, efficiency checks are done to verify that the developed device improves patients’ outcome. The mentioned approach ensures that device manufacturers remain innovative to introduce improved contrivances for ease of approval. The second similarity between the two systems is that they are both designed in such a way that they protect the patients from harm. Before the introduction of a new device for patient use, it has to be screened to ensure that patients’ safety is guaranteed. In Europe, the Competent Authorities handle safety checks processes before a device can be approved by the Notified Bodies (Kashyap, Gupta, and Raghunandan 123). The FDA conducts safety checks in the US, and a machine is only approved if it satisfies the safety requirements. Under both systems, manufacturers are required to report any adverse results to mitigate the risks accruing to patients after treatment using such devices. The obligation is illustrative of the commitment by the duo systems to patients’ safety while at the same time allowing innovation. The third similarity evident under the two systems is that the safety procedures increases with the risks involved. Manufacturers of low-risk devices (class 1) are only required to declare that the machine meets the set standards. The case is different for the high-risk devices that require more elaborate safety checks before approval. In the US, the high-risk devices are subject to strict clinical and safety trials before approval. The approval process for the high-risk devices may take up to a year. Just like in the US, in Europe, the low-risk devices are appr