Session (CTI)

ISSUE: Medical devices present specific assessment challenges because of their heterogeneity, frequent product updates, dependence on context of use, and potential to alter care pathways. Demonstrating their clinical and economic value is therefore often more complex and less standardized than for other health technologies. Real-world data (RWD) and the resulting real-world evidence (RWE) can help address these challenges by showing how devices perform in routine clinical practice, including effectiveness, safety, and patterns of use across broader patient populations than those typically included in pre-market studies. Despite the growing use and submission of real world data and evidence, why do HTA bodies still often consider it insufficient for decision making? This session will explore three questions: What criteria do decision makers use to assess the relevance of RWD for medical devices? Which types of RWD are most useful across the technology lifecycle? What solutions could strengthen the RWD/RWE ecosystem and improve its acceptability for HTA? OVERVIEW: Medical devices require a tailored and continuous approach to assessment because of their clinical, economic, and organizational impacts. While RWD/RWE can contribute meaningfully, HTA for medical devices is not systematic across all European countries and is not always directly linked to decision-making. The EU HTA Regulation, which includes high-risk medical devices from June 2026, aims to better align clinical assessments across Member States. In parallel, the EHDS Regulation may facilitate secondary use of health data and improve its fitness for purpose. The moderator will open with a 10-minute overview, followed by a 40-minute panel discussion and 10 minutes for Q&A audience. This session will be of particular interest to medical device industry representatives, HTA stakeholders, and HEOR researchers.