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New Variation Classification Guideline Adjustment of the Joint Announcement (BfArM and PEI) on the notification of variations for purely national authorisations FASTEU Pilot to accelerate authorization of multinational clinical trials in the EU/EEA Functionality of EUDAMED The use of EUDAMED will be mandatory for the registration of medical devices and in vitro diagnostics as well as certificates according to MDR and IVDR from 28 May 2026

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Chen, W.F., Huang, S.Y., Liao, C.Y., Sung, C.S., Chen, J.Y., and Wen, Z.H., Biomaterials , 2015, vol

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