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[Emergo, UL] Gradual roll-out of EUDAMED

MD우야 2024. 12. 20. 12:30
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When to expect the first modules of EUDAMED to become mandatory

By Annette van Raamsdonk

After several meetings, consultations and a draft version, the final version of the Questions and Answers (Q&A) on EUDAMED was published a few weeks ago, in November. The Q&A document is a guidance document giving practical information on the new requirements, which followed Amendment (EU) 2024/1860, which we have previously informed you about. In this blog, we will give you some of the highlights from the Q&A document, covering 20 questions.

 

 

Gradual roll-out of EUDAMED | Emergo by UL

 

Gradual roll-out of EUDAMED

When to expect the first modules of EUDAMED to become mandatory for medical devices and IVDs in the EU.

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