The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.