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Tuesday, May 16th

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1st revision of the guidance MDCG 2020-3 on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 and guidance MDCG 2022-6, and to introduce clarifications and examples of what is to be considered as a significant change or not.

DOWNLOAD THE GUIDANCE MDCG 2020-3 Rev.1

1st revision of the guidance MDCG 2020-3 on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

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