OBJECTIVES: Recent events in Europe and the US have brought into question the effectiveness of existing regulatory frameworks to ensure the performance, safety, and quality of new medical devices. Given that policymakers are currently exploring ways to reform medical device regulation to address these issues, this study aimed to examine current medical device regulation policies in both jurisdictions, understand outstanding regulatory challenges, and identify ways to improve regulatory practices. METHODS: The study examined the respective regulatory systems based on a critical review of available, relevant scientific and grey literature. In addition, the websites of national medical device regulatory agencies (e.g., FDA) were reviewed for key legislative and policy documents. RESULTS: The review highlighted a number of challenges for medical device regulation in both jurisdictions: 1) finding the right balance between centralized and decentralized regulation; 2) ensuring sufficient evidence requirements to safeguard public health and certify performance, especially for high-risk devices; 3)  implementing mechanisms and incentives for monitoring and evaluating post-market device safety and effectiveness; and, 4) providing adequate and transparent information exchange on the benefits and risks of new technologies. To address these issues, European and US policy makers and other stakeholders have implemented various initiatives or are considering their introduction. Specific policies include establishing a more centralized system of regulation in Europe; requiring uniform oversight and evidence requirements across and within European countries; and, use of national and European databases to track and monitor medical devices as well as registries to collect post-market data on effectiveness and safety. CONCLUSIONS: Additional actions are needed to ensure high-performing medical device regulation. These include providing sufficient incentives for manufacturers to conduct pre-market clinical studies, making market access conditional on rigorous post-marketing studies when available evidence is absent or limited, promoting international registry coordination, and bolstering information on the evidentiary basis for granting CE marks in Europe.