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EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5.

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Title: EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5.
Authors: Cobbaert C; Department of Clinical Chemistry and Laboratory Medicine, Leiden, Netherlands., Neumaier M; Institute for Clinical Chemistry, Mannheim, Germany., Capoluongo E; Department of Molecular Medicine and Medical Biotechnology, Federico II University, Naples, Italy.; Department of Laboratory Medicine, Rome, Italy., Mullier F; Université Catholique de Louvain, CHU UCL NAMUR, NTHC, Narilis, Yvoir, Belgium., Orth M; Vinzenz von Paul Kliniken gGmbH, Institut für Laboratoriumsmedizin Stuttgart, Germany.; Medizinische Fakultät Mannheim, Ruprecht Karls Universität Heidelberg, Mannheim, Germany., Streichert T; Institute for Clinical Chemistry, Cologne, Germany., Bhattoa HP; Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary., Bossuyt P; Department of Epidemiology and Data Science, Amsterdam UMC, Netherlands., Barbosa LB; Department of Clinical Pathology, Unidade Local de Saúde de Coimbra, Coimbra, Portugal., Plebani M; Department of Medicine-DIMED, University of Padova, Padova, Italy., Zima T; Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic.
Corporate Authors: European Federation of Laboratory Medicine (EFLM)
Source: Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2026 May 07; Vol. 64 (7), pp. 1455-1466. Date of Electronic Publication: 2026 May 07 (Print Publication: 2026).
Publication Type: Journal Article
Journal Info: Publisher: Walter De Gruyter Country of Publication: Germany NLM ID: 9806306 Publication Model: Electronic-Print Cited Medium: Internet ISSN: 1437-4331 (Electronic) Linking ISSN: 14346621 NLM ISO Abbreviation: Clin Chem Lab Med Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5.
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  Data: <searchLink fieldCode="AU" term="%22Cobbaert+C%22">Cobbaert C</searchLink>; Department of Clinical Chemistry and Laboratory Medicine, Leiden, Netherlands.<br /><searchLink fieldCode="AU" term="%22Neumaier+M%22">Neumaier M</searchLink>; Institute for Clinical Chemistry, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Capoluongo+E%22">Capoluongo E</searchLink>; Department of Molecular Medicine and Medical Biotechnology, Federico II University, Naples, Italy.; Department of Laboratory Medicine, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Mullier+F%22">Mullier F</searchLink>; Université Catholique de Louvain, CHU UCL NAMUR, NTHC, Narilis, Yvoir, Belgium.<br /><searchLink fieldCode="AU" term="%22Orth+M%22">Orth M</searchLink>; Vinzenz von Paul Kliniken gGmbH, Institut für Laboratoriumsmedizin Stuttgart, Germany.; Medizinische Fakultät Mannheim, Ruprecht Karls Universität Heidelberg, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Streichert+T%22">Streichert T</searchLink>; Institute for Clinical Chemistry, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Bhattoa+HP%22">Bhattoa HP</searchLink>; Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.<br /><searchLink fieldCode="AU" term="%22Bossuyt+P%22">Bossuyt P</searchLink>; Department of Epidemiology and Data Science, Amsterdam UMC, Netherlands.<br /><searchLink fieldCode="AU" term="%22Barbosa+LB%22">Barbosa LB</searchLink>; Department of Clinical Pathology, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.<br /><searchLink fieldCode="AU" term="%22Plebani+M%22">Plebani M</searchLink>; Department of Medicine-DIMED, University of Padova, Padova, Italy.<br /><searchLink fieldCode="AU" term="%22Zima+T%22">Zima T</searchLink>; Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic.
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  Data: <searchLink fieldCode="CA" term="%22European+Federation+of+Laboratory+Medicine+%28EFLM%29%22">European Federation of Laboratory Medicine (EFLM)</searchLink>
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  Data: <searchLink fieldCode="JN" term="%229806306%22">Clinical chemistry and laboratory medicine</searchLink> [Clin Chem Lab Med] 2026 May 07; Vol. 64 (7), pp. 1455-1466. <i>Date of Electronic Publication: </i>2026 May 07 (<i>Print Publication: </i>2026).
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Walter+De+Gruyter%22">Walter De Gruyter </searchLink><i>Country of Publication: </i>Germany <i>NLM ID: </i>9806306 <i>Publication Model: </i>Electronic-Print <i>Cited Medium: </i>Internet <i>ISSN: </i>1437-4331 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214346621%22">14346621 </searchLink><i>NLM ISO Abbreviation: </i>Clin Chem Lab Med <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42089505
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              Text: 2026 May 07
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