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. 2021 Jul 21;56(1):47–64. doi: 10.1007/s43441-021-00323-7

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© The Author(s) 2021

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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Although the IVDR does not include a definition of LDTs, there are four major scenarios for the qualification and demarcation of “devices manufactured and used only within health institutions” based on the laboratory’s intention that the product or product combination is intended to be used for in vitro diagnostic examination purposes.