ISSUE: How to robustly compare alternative interventions involving different medical devices (MDs) when randomized controlled trials (RCTs) are missing and only single arm observational studies are available? Why should RCTs matter at all if patients’ heterogeneity and clinical proficiency have such a formidable influence on the MD’s performance? Isn’t it better to assess the value of MDs with real world data (RWD) alone instead? The methodological concerns with the analysis of RCTs and RWD will be discussed from academic academic (RT) and HTA agency (CI) perspective. The challenges with the collection of RCTs and RWD will be addressed from manufacturer standpoint (KK). In addition to that, the panel will discuss whether there is a need for a new framework for value assessment of MDs. Panelists will present their experiences and perspectives related to the question whether RWD alone can ensure objectiveness and feasibility of the estimation of clinical and economic benefits of MDs. OVERVIEW: In 2015, there were more than twice as many patents granted for new MDs than drugs. As the market grows, there is an increased understanding of the need to assess the value of MDs. Following new MD directive (MDR 2017/745), some experts reinforce the importance of clinical data in the search of MD’s value. It is provoking to ask whether RCTs can truly provide the relevant evidence for the clinical and economic benefits. MD’s efficacy and safety is in fact determined not only by its technical capabilities but also patients’ characteristics as well as end user experience. The challenge to assess MD’s value is related to the difficulties with the choice of a comparator too. The complexity of clinical pathways introduces multiple alternative treatment options. Sometimes they are used simultaneously for the benefit of patient. Consequently, clinical efficacy can differ significantly from the real life effectiveness. The recent developments such as the introduction of FDA guidelines ”Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” draw more and more attention to the usefulness of RWD in the decision making processes. It can therefore be asked whether RWD can substitute RCTs in the assessment of the value of MDs or we need to pursue both. This panel will attempt to address the pros and cons of the replacement of RCTs with RWD in the pricing & reimbursement process for MDs.