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Monday, November 25th

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First revision of the MDCG 2023-3: Q&A on vigilance terms and concepts as outlined in the Regulations (EU) 20217/745 and 2017/746

In November 2024, the MDCG published a revision of the several questions listed in its Q&A on vigilance terms and concepts as outlined in the MDR and IVDR.

On a general note, new questions were added, the term ‘Regulations’ and references to IVDR articles were inserted, adjustments all over the document to align it to the latter were made, and a table of contents was included to provide a general overview of the document.

DOWNLOAD THE MDCG 2023-3 Rev.1

First revision of the MDCG 2023-3: Q&A on vigilance terms and concepts as outlined in the Regulations (EU) 20217/745 and 2017/746

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