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. 2022 May 20;6(6):e724. doi: 10.1097/HS9.0000000000000724

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Copyright © 2022 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 3. — Timelines for revised phased IVDR implementation. The General Safety and Performance Requirements specified in Annex I as well as Article 5.5 (with the exception of 5.5b to i) are not mentioned in the amendment and are, as such, applicable from May 2022. CE-IVDs = CE marked in vitro diagnostics; IH-IVDs = in-house in vitro diagnostics; IVDR = Regulation (EU) 2017/746 on in vitro diagnostic medical devices.