TY - JOUR
T1 - Structure and content of the EU-IVDR
T2 - Current status and implications for pathology
AU - Kahles, Andy
AU - Goldschmid, Hannah
AU - Volckmar, Anna Lena
AU - Ploeger, Carolin
AU - Kazdal, Daniel
AU - Penzel, Roland
AU - Budczies, Jan
AU - Kempny, Gisela
AU - Kazmierczak, Marlon
AU - Flechtenmacher, Christa
AU - Baretton, Gustavo
AU - Weichert, Wilko
AU - Horst, David
AU - Klauschen, Frederick
AU - Gassner, Ulrich M.
AU - Brüggemann, Monika
AU - Vogeser, Michael
AU - Schirmacher, Peter
AU - Stenzinger, Albrecht
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/11
Y1 - 2023/11
N2 - 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.
AB - 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.
KW - Diagnostic reagent kits
KW - Government regulation
KW - In-house production
KW - Laboratory-developed tests
KW - Quality of healthcare
UR - http://www.scopus.com/inward/record.url?scp=85147368685&partnerID=8YFLogxK
U2 - 10.1007/s00292-022-01176-z
DO - 10.1007/s00292-022-01176-z
M3 - Review article
AN - SCOPUS:85147368685
SN - 2731-7188
VL - 44
SP - 73
EP - 85
JO - Pathologie
JF - Pathologie
ER -