Abstract
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021.
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CITATION STYLE
Kahles, A., Goldschmid, H., Volckmar, A.-L., Ploeger, C., Kazdal, D., Penzel, R., … Stenzinger, A. (2023). Structure and content of the EU-IVDR. Die Pathologie, 44(S2), 73–85. https://doi.org/10.1007/s00292-022-01176-z
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