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

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

Bart R Lubbers  1 , Anke Schilhabel  2 , Christa M Cobbaert  3 , David Gonzalez  4 , Isabel Dombrink  2 , Monika Brüggemann  2 , W Marieke Bitter  1 , Jacques J M van Dongen  1
Affiliations
Editorial

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

Bart R Lubbers et al. Hemasphere. .
No abstract available

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Figures

Figure 1.
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.
Figure 2.
Figure 2.
Use of IH-IVDs by hospitals and laboratories in the Netherlands. Pie chart shows the share of institutions that use no in-house devices (IH-IVDs; ie, 100% CE-IVDs), >0%–25%, 25%–50%, 50%–75%, 75%–100%, or >0% (percentage not specified) IH-IVDs. Approximately 2 of 3 laboratories have implemented IH-IVDs (all blue slices combined) and in almost 1 of 4 laboratories more than half of the implemented IVDs are IH-IVDs (2 darkest slices combined). The graph was made based on data from the Dutch National Institute for Public Health and the Environment (RIVM), 2015. CE-IVDs = CE marked in vitro diagnostic medical devices; IH-IVDs = in-house in vitro diagnostic medical devices.
Figure 3.
Figure 3.
Assay inventory and IVDR compliance workflow. The assay inventory decision tree allows laboratories to plan their assay portfolio under the IVDR based on the tests that are currently implemented. Key questions are whether current CE-IVD tests will be CE marked under the IVDR (for the same intended purpose) and whether appropriate alternatives for in-house devices (IH-IVDs) are available (see also the discussion on IVDR Art. 5(5)d,e). Subsequently, for all IH-IVDs that are used after May 2022, the conditions and requirements for IH-IVDs as dictated by the IVDR should be fulfilled. The most important requirements are listed above and are discussed in more detail in the main text. Finally, fulfillment of the requirements should be documented in the technical documentation and publicly stated in the declaration of conformity. CE-IVDs = CE marked in vitro diagnostic medical devices; IH-IVDs = in-house in vitro diagnostic medical devices; IVDR = Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
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References

    1. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 2017. Available at: https://eur-lex.europa.eu/eli/reg/2017/746. Accessed April 8, 2021.
    1. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. 1998. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31998L0079. Accessed April 8, 2021.
    1. van Drongelen A, de Bruijn A, Pennings J, van der Maaden T. The impact of the new European IVD classification rules on the notified body involvement; a study on the IVDs registered in the Netherlands. RIVM Letter Report. 2018;2018-0082:1–32.
    1. MedTech Europe. Clinical Evidence Requirements for CE certification under the in-vitro Diagnostic Regulation in the European Union. 2020. Available at: https://www.medtecheurope.org/resource-library/clinical-evidence-require.... Accessed March 12, 2021.
    1. European Commission. Nando (New Approach Notified and Designated Organisations) Information System: Notified bodies designated for the IVDR. Available at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=d.... Accessed March 12, 2021.

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