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22 December 2025: Clinical investigation/performance study (KP/LS) in accordance with MDR, IVDR and MPDG

A new guidance for sponsors has been published: Clinical investigation/performance study (KP/LS) in accordance with MDR, IVDR and MPDG

22 December 2025: Clinical investigation/performance study (KP/LS) in accordance with MDR, IVDR and MPDG PDF, 1,005KB, File is accessible