Mastering EUDAMED: Current Framework and Implementation Strategies

EUDAMED (European Database on Medical Devices) is a central information system for the lifecycle of medical devices and in vitro diagnostic (IVD) devices in the EU and is a fundamental part of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It is designed to enhance transparency, traceability, and improve coordination among stakeholders, including manufacturers, notified bodies, and competent authorities. It interconnects economic operator information, device details, and vigilance data to provide comprehensive oversight and alignment.

EUDAMED is expected to become mandated in 2026 and to ensure successful EUDAMED implementation, companies need to have a deep understanding of how this system works and prepare well, given the level of data required. This session is designed to demystify EUDAMED by clarifying its objectives and timelines. We'll provide a comprehensive overview of the roles of various actors and UDI requirements and assess whether EUDAMED truly enables the intended standardization. Additionally, we'll explore the connection with swissdamed. Participants will gain valuable insights into the current EUDAMED framework, learn essential steps for compliance, identify common pitfalls, and benefit from shared experiences.