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During the IEC TC62 / SC62A meetings in Seoul, South Korea, 18 – 22 Sept 2023 there was general consensus between the National Committees (NCs) to move forward with the IEC 60601-1 4th edition project. Yeah, finally after so many years!!!!
Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list. But the FDA only Partially Recognized IEC 61326-1:2020 and