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

Andy Kahles, Hannah Goldschmid, Anna Lena Volckmar, Carolin Ploeger, Daniel Kazdal, Roland Penzel, Jan Budczies, Gisela Kempny, Marlon Kazmierczak, Christa Flechtenmacher, Gustavo Baretton, Wilko Weichert, David Horst, Frederick Klauschen, Ulrich M. Gassner, Monika Brüggemann, Michael Vogeser, Peter Schirmacher, Albrecht Stenzinger

Research output: Contribution to journalReview articlepeer-review

6 Scopus citations

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.

Translated title of the contributionStruktur und Inhalt der EU-IVDR: Bestandsaufnahme und Implikationen für die Pathologie
Original languageEnglish
Pages (from-to)73-85
Number of pages13
JournalPathologie
Volume44
DOIs
StatePublished - Nov 2023
Externally publishedYes

Keywords

  • Diagnostic reagent kits
  • Government regulation
  • In-house production
  • Laboratory-developed tests
  • Quality of healthcare

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