ISSUE: The use of real-world evidence (RWE) for the assessment of medical devices often encounters the scientific community skepticism in the absence of experimental evidence, even in case of devices commonly used in current practice. The goal of the session is to discuss how and to what extent real world studies can provide relevant evidence to decision-makers. The panel will be structured as a debate, started with short presentations (1 or 2 slides) showing the different perspectives, followed by a discussion moderated by Rosanna Tarricone, enlightening the current different perspectives. Armeni (health economist) will present the paradox between the logical order of decisions (RCTs for approval should anticipate RWE for reimbursement) and the fact that RWE could be available much sooner than RCTs and in the case of medical devices RCTs cannot always grant high-quality evidence. Sebastian Schneeweiss (MD) will illustrate the concern about the quality and diffusion of RWE and will present the scientific critical perspective on the role of RWE as source of information for adoption and reimbursement decisions. Richard Charter (industry) will discuss the current uncertainty faced by firms in planning the generation of evidence to be submitted to regulators and payers. Rosanna Tarricone will moderate the discussion and summarize the current different perspectives, identifying the next steps to move RWE towards a clearer understanding and a larger consensus about their role. OVERVIEW: Real-world studies (RWS) are increasingly recognised as a valuable source of clinical evidence for HTA purposes, especially when randomized clinical trials (RCTs) are either not available, difficult to realise, unethical or available but not helpful for decision making. Clinical evidence drawn from RWS will never be as reliable as that drawn from a perfect RCT in identifying a causal relationship. However, there are three reasons to encourage the production of RWS for the HTA of medical devices. First, when the ideal RCT design is not feasible, selection bias is inherent also to experimental studies. Second, the research question of RWS is different: they do not aim at showing whether a technology works but, instead, if it can work in actual clinical practice and under a specific resource constraint. Policy makers should assess whether it’s worth investing in a new technology and should, therefore, be more concerned with evidence produced in real settings rather than experimental ones. Third, RWS are more prompt and less costly than RCTs. However, the scientific community is currently concerned about the quality of evidence produced in RWS, and fear that an excessive enthusiasm about RWS can lead to the abandon of the experimental evidence in favour of RWE, with the risk of confusing the issue of safety and efficacy with the proof of cost-effectiveness and sustainability.