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editorial

. 2021 Apr 21;5(5):e568. doi: 10.1097/HS9.0000000000000568

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Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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Figure 1. — Relation between the ISO 15189 standard and the IVDR. Given the important overlap between ISO 15189 and the IVDR, in particular regarding equipment, reagents and other in vitro diagnostic medical devices, ISO 15189 is an important basis for compliance to the IVDR for diagnostic laboratories. At the same time, ISO 15189 covers a much broader range of quality aspects, including management, personnel, and reporting. IVDR = Regulation (EU) 2017/746 on in vitro diagnostic medical devices.