The NEED (Needs Examination, Evaluation, and Dissemination) assessment framework was designed to identify and measure unmet health-related needs of patients and society across various health conditions, aiding the development of needs-driven healthcare policy and innovation. The framework consists of 25 needs criteria and 46 associated indicators that assess whether these needs are met or not. This study aims to validate the framework at the European Union (EU) level using a modified Delphi approach. We selected national and European institutes for the Delphi process based on their roles in public health, health technology assessment (HTA), medicine authorization, pricing and reimbursement (P&R), and patient advocacy. Using a modified Delphi approach, experts provided feedback on the framework's structure (dimensions and domains), health-related needs criteria, and indicators. Two Delphi rounds were conducted via online questionnaires. A panel of 26 experts participated in both rounds of the study. The majority of the participants reported expertise in HTA (50%) and P&R (15%), followed by patient advocacy (15%) and public health (8%). Seventeen EU Member States were represented, with a higher representation of experts from Belgium (12%) and Germany (12%). The NEED framework based on expert consensus consists of 4 dimensions, 3 domains, 24 criteria, and 43 indicators. The modified Delphi technique proved effective for validating the NEED framework at the EU level. This marks a critical first step toward consensus on defining and identifying unmet health-related needs, paving the way for a more needs-driven healthcare policy and innovation landscape.