Expenditure on medical devices is substantial and is expected to grow in the future. This Editorial draws attention to health economic issues surrounding medical devices. To this effect, opportunities and challenges involved in the economic analysis of the market structure of medical device sectors and in the economic evaluation of medical devices are identified. Markets for medical devices tend to be fragmented and suffer from a lack of transparency and competition. In response to this, there is extensive government intervention in many developed countries with a view to keeping down prices, restricting public reimbursement and promoting an efficient use of medical devices. Studies are called for that evaluate and compare country approaches towards regulating medical device markets with a view to informing medical-device policies. Whereas economic evaluation of medicines is well established, and is used to inform pricing and reimbursement decisions in many developed countries, this is less the case for medical devices. There is a need for economic evaluations of medical devices with a view to demonstrating their cost effectiveness. In addition, countries need to implement frameworks for the assessment of new and emerging medical devices with a view to taking pricing and reimbursement decisions.