OBJECTIVES: There is growing concern about the unsustainable rise in health care costs and whether such spending levels are commensurate with better quality of care and improved health outcomes. Consequently, policy makers are aiming to attain greater value from new technologies. This study sought to examine existing reimbursement and pricing policies for medical devices in Europe and the US, identify key challenges in defining and assessing their value, and explore various policy options to obtain greater value from these technologies. METHODS: The study examined the respective reimbursement and pricing systems for medical devices based on a critical review of available, relevant scientific and grey literature. In addition, the websites of national payers (e.g., CMS) and HTA bodies (e.g., NICE) were reviewed for key policy documents. RESULTS: Current reimbursement and pricing systems for medical devices in both Europe and the US raise a number of issues: 1) the majority of countries apply the same assessment and reimbursement and pricing frameworks to all technologies; 2) most funding decisions in the US are made at the local level, where policies and evidence standards can vary across states/payers; 3) where evidence of value is used in decision making, notably in Europe, it is generally better linked to coverage determinations, as opposed to identifying appropriate reimbursement prices; and 4) a number of methodological challenges exist for measuring the value of devices, including generating evidence of effectiveness via RCTs, accounting for the ‘learning curve’ of clinicians as well as the complex impact of medical devices on health systems, and capturing some of the benefits afforded by medical devices (e.g., increased patient convenience).   CONCLUSIONS: New policies focused on improving the clinical and economic base on devices, developing new approaches to assess their value, and strengthening the link between reimbursement and evidence of value are needed.