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Review
. 2023 Nov;44(Suppl 2):73-85.
doi: 10.1007/s00292-022-01176-z. Epub 2023 Feb 3.

Structure and content of the EU-IVDR : Current status and implications for pathology

Andy Kahles  1 , Hannah Goldschmid  2 , Anna-Lena Volckmar  2 , Carolin Ploeger  2 , Daniel Kazdal  2 , Roland Penzel  2 , Jan Budczies  2 , Gisela Kempny  3 , Marlon Kazmierczak  3 , Christa Flechtenmacher  2 , Gustavo Baretton  4 , Wilko Weichert  5 , David Horst  6 , Frederick Klauschen  7 , Ulrich M Gassner  8 , Monika Brüggemann  9 , Michael Vogeser  10 , Peter Schirmacher  2 , Albrecht Stenzinger  11
Affiliations
Review

Structure and content of the EU-IVDR : Current status and implications for pathology

Andy Kahles et al. Pathologie (Heidelb). 2023 Nov.

Abstract

Background: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-certified IVDs (CE-IVDs), in-house IVDs (IH-IVDs), and research use only (RUO) devices are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities.

Objectives: Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge.

Conclusions: The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments.

Keywords: Diagnostic reagent kits; Government regulation; In-house production; Laboratory-developed tests; Quality of healthcare.

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Conflict of interest statement

A.-L. Volckmar: personal fees from AstraZeneca outside the submitted work. D. Kazdal: personal fees from AstraZeneca, Bristol-Myers Squibb, Pfizer, Lilly, Agilent, and Takeda outside the submitted work. W. Weichert: advisory boards and invited speaker for Roche, MSD, BMS, AstraZeneca, Pfizer, Merck, Lilly, Boehringer, Novartis, Takeda, Bayer, Janssen, Amgen, Astellas, Illumina, Eisai, Siemens, Agilent, ADC, GSK, and Molecular Health; research support by Roche, MSD, BMS, and AstraZeneca. M. Brüggemann: advisory boards and invited speaker for Amgen, BD, Janssen, art tempi communications, Pfizer, Research support by Amgen. A. Stenzinger: advisory board/speaker: AGCT, Aignostics, Astra Zeneca, Bayer, BMS, Eli Lilly, Illumina, Incyte, Janssen, MSD, Novartis, Pfizer, Roche, Seattle Genetics, Takeda, Thermo Fisher; grants: Bayer, BMS, Chugai, Incyte. P. Schirmacher: Speakers bureau: Incyte, Roche, Janssen, Novartis, AstraZeneca, BMS, Eisai, Board: Incyte, Roche, AstraZeneca, BMS, MSD, Amgen, Janssen, Novartis, Bayer, Eisai, Grant support: Novartis, BMS, AstraZeneca, Illumina, Gilead, Falk. A. Kahles, H. Goldschmid, C. Ploeger, R. Penzel, J. Budczies, G. Kempny, M. Kazmierczak, C. Flechtenmacher, G. Baretton, D. Horst, F. Klauschen, U.M. Gassner and M. Vogeser declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
a Process chain in the analytics of health institutions. b Each link in the process chain (a) from specimen receipt to diagnostic findings may contain devices that can be assigned to either general laboratory use (purple), CE-marked in vitro diagnostic devices (CE-IVD, orange), or in-house developed IVDs (IH-IVD, blue)
Fig. 2
Fig. 2
Exemplary process chain within pathology institutes from request to reporting to diagnosis using various CE-marked (CE-IVD) and in-house in vitro diagnostic devices (IH-IVD). FFPE formalin-fixed paraffin-embedded, IHC immunohistochemistry, NGS next-generation sequencing, RUO research use only, IVDR regulation on in vitro diagnostic devices
Fig. 3
Fig. 3
Regulation 2017/746 on in vitro diagnostic devices (IVDR)—Article 5 (5) [31]
Fig. 4
Fig. 4
Required documentation for the use of an in-house in vitro diagnostic device (IH-IVD) in health institutions with reference to the regulation on in vitro diagnostic devices (IVDR; green). These documents do not necessarily apply to all devices and may not be complete. SOP standard operating procedure
Fig. 5
Fig. 5
Elements from Annex I, which are necessary for the fulfillment of the essential safety and performance requirements. These elements do not necessarily apply to all devices and may not be complete
See this image and copyright information in PMC

References

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