Description: When fully operational, EUDAMED will provide a holistic view of the regulatory lifecycle for medical devices sold in the European Union, increasing transparency and coordination among EU member states as a result. Many medtech manufacturers have started submitting or are thinking about submitting data voluntarily as part of their transition to a world with EUDAMED. However, shifting implementation timelines and requirements coupled with adjustments to industry strategy for the EU market have led many medtech regulatory teams to question how they should take recent and forthcoming EUDAMED updates into account. In this session, we’ll discuss common EUDAMED questions and share strategies to help medtech quality assurance and regulatory affairs teams prepare themselves for the full EUDAMED rollout.
Learning Objectives:
The EU MDR/IVDR amendment for EUDAMED and considerations
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