The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories

Bart R Lubbers, Anke Schilhabel, Christa M Cobbaert, David Gonzalez, Isabel Dombrink, Monika Brüggemann, W Marieke Bitter, Jacques J M van Dongen

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Abstract

On May 26, 2022, after a transitional period of 5 years, the new Regulation (EU)2017/746 on in vitro diagnostic medical devices1 (IVDR; Table 1) will fully replace Directive 98/79/EC on in vitro diagnostic medical devices2 (IVDD). The aim of the IVDR is to further establish a well-regulated and smoothly functioning market for invitro diagnostic medical devices (IVDs; Box 1) within the European Union (EU) that is better aligned with international guidelines. Moreover, following vast technical and medical developments during the previous 2 decades—for example, in the area of genetic testing and companion diagnostics—it was deemed critical to secure protection of safety and health by setting high standards for safety and performance of IVDs. Both the IVDD and IVDR dictate that, depending on their intended use/purpose (and associated risk), IVDs either have to be assessed and certified by an independent third party (a notified body) or can be self-certified by their manufacturer. After certification, manufacturers are allowed to label products with the “Conformité Européenne” (CE)mark, which is required to distribute and sell “CE-IVD” products on the EU market. Even though both legislations share the general concept of IVD certification and CE marking, a much wider range of IVDs will have to be certified by notified bodies and more(clinical) performance data and documentation will be required to legitimately commercialize IVDs under the IVDR. However, the replacement of the IVDD by the IVDR will not only have major consequences for manufacturers of IVDs but also for all diagnostic laboratories. This report aims to help diagnostic laboratories understand the scope of the IVDR and its consequences for commercially available CE-IVDs and, even more importantly, for in-house devices (IH-IVDs). Although many aspects of the IVDR still have to be clarified, laboratories are urged to take a number of actions to prepare for this new regulation.
Original languageEnglish
Article numbere568
Number of pages9
JournalHemaSphere
Volume5
Issue number5
DOIs
Publication statusPublished - 01 May 2021

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