OBJECTIVES: Market Access (MA) is key for medical devices given recent changes in regulation from one side, and pressures on costs from the other side. Nevertheless, there is scant evidence on how MA works in the medical device industry and whether it works effectively. The aims of the present study are to illustrate current gaps in MA for medical devices and to recommend future actions to make this function more effective. METHODS: We conducted a literature review aimed at gathering a clear picture of current state of the art on MA for medical devices and at highlighting major gaps vis-à-vis other industries (e.g. pharmaceuticals). Based upon the review’s findings, we carried out an e-survey to small, medium, and large device companies operating in the EU in order to understand: i) how MA is perceived and actually organised, ii) which are the main perceived obstacles to MA, iii) how companies invest in market access and at which stage of medical device development, and iv) what the main challenges are to a more efficient market access process. RESULTS: The findings of the literature review and preliminary results of the e-survey are presented. CONCLUSIONS: MA is an under-developed function in the medical device industry and in certain cases its role is not fully exploited. Although the pharmaceutical industry doesn’t represent a fully appropriate benchmark, MA for medical devices is even less developed when compared to its full potential. A different approach is needed to deal with new changes in the regulation and policy arenas aimed at synergistically encompassing knowledge, expertise and operating tools from public affairs, medical departments, pricing & reimbursement, health economics and marketing.