ISSUE: Medical devices (MDs) often obtain market authorization with less evidence on effectiveness than other health technologies. This is mainly because of the lack of a legal requirement to conduct adequately controlled clinical studies, as is the case for pharmaceuticals. The lack of effectiveness evidence, especially comparative effectiveness evidence, limits the possibilities for health technology assessment (HTA). Therefore, it is important to discuss what incentives can be given to improve the quality and quantity of the effectiveness evidence for MDs. OVERVIEW: Medical devices (MDs) often obtain market authorization with much less evidence on clinical effectiveness than other health technologies. This is mainly because of the lack of a legal requirement to conduct adequately controlled clinical studies. Also, HTA agencies often accept claims of equivalence, which further reduces the incentives to manufacturers to conduct adequately controlled clinical studies, since they could spend time and effort collecting clinical evidence that a ‘fast-followers’ can claim also applies equally to their own product. Therefore, although device manufacturers have patent protection, they are not granted data exclusivity in the same way as pharmaceuticals. The lack of effectiveness evidence, especially comparative effectiveness evidence, limits the possibilities for health technology assessment, although effectiveness evidence can be gathered pre-market (i.e. through conducting controlled clinical trials in an experimental setting), or post-market, through clinical studies undertaken in regular clinical practice. Post-market effectiveness research may be more important for MDs than pharmaceuticals, as the performance of the device often depends on the interaction with the user (the so-called learning curve). This suggests that the solution to the problem of inadequate effectiveness evidence should address the issue of conducting clinical research in both the pre- and post-market phase. This panel will discuss the incentives that could be given to increase the range and quality of effectiveness evidence both pre- and post-marketing of MDs.