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Licensed Unlicensed Requires Authentication Published by De Gruyter November 23, 2020

The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications

Paul C.D. Bank, Leo H.J. Jacobs, Sjoerd A.A. van den Berg, Hanneke W.M. van Deutekom, Dörte Hamann, Richard Molenkamp, Claudia A.L. Ruivenkamp, Jesse J. Swen, Bastiaan B.J. Tops, Mirjam M.C. Wamelink, Els Wessels and Wytze P. Oosterhuis

Abstract

The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.


Corresponding author: Leo HJ. Jacobs, Chair Dutch Task Force IVDR, Department Laboratory of Clinical Chemistry, Meander Medical Center 3813 TZ, Amersfoort, The Netherlands, Phone: +31 (0)33 850 5050, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-1384).


Received: 2020-09-14
Accepted: 2020-10-20
Published Online: 2020-11-23
Published in Print: 2021-02-23

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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