EU - Updates to the list of harmonised standards for MDR and IVDR

On 2024-10-08 the EU published amendments with harmonised standards for Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the official journal (implementing decision (EU) 2024/2631 and (EU) 2024/2625).. The number of harmonised standards increases by one for the MDR (to now 25) and by two for the IVDR (to now 15).

Consolidated summary lists of the harmonised standards are published here for the MDR and hier for the IVDR.

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