This document offers a detailed Q&A guide on the progressive implementation of Eudamed, in accordance with the MDR, IVDR, and the amendments introduced by Regulation (EU) 2024/1860. It explains the phased implementation strategy, outlining how different modules of Eudamed, such as registration of devices, actors, and clinical investigations, will be introduced. The guide also addresses practical concerns, including data submission requirements, transitional measures, and timelines for full compliance, making it a critical resource for manufacturers, authorized representatives, and other stakeholders in the medical device industry.


Additionally, the document elaborates on obligations related to reporting supply chain interruptions or discontinuations, particularly for legacy devices, and the transitional provisions that apply to in vitro diagnostic devices. It provides clarification on compliance deadlines, ensuring stakeholders understand their responsibilities during the transition to the fully operational Eudamed system. This article is particularly helpful for industry professionals looking for clear and practical insights into navigating the complexities of regulatory changes while maintaining compliance with EU requirements.


If you wish to explore the detailed Q&A, please refer to the reference.

 

Reference:
Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860

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