ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro -Diagnostics Regulation.
| Autor: | Vanstapel FJLA; Laboratory Medicine, University Hospital Leuven, Leuven, Belgium.; Department of Public Health, Biomedical Sciences Group, Catholic University Leuven, Leuven, Belgium., Orth M; Institute of Laboratory Medicine, Vinzenz von Paul Kliniken gGmbH, Stuttgart, Germany.; Medical Faculty Mannheim of Heidelberg University, Mannheim, Germany., Streichert T; University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Capoluongo ED; Dipartimento di Medicina Molecolare e Biotecnologie Mediche, Università Federico II, Naples, Italy., Oosterhuis WP; Department of Clinical Chemistry, Reinier Haga Medical Diagnostic Centre, Delft, The Netherlands., Çubukçu HC; Ankara University Stem Cell Institute, Ankara, Türkiye.; Department of Rare Diseases, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Türkiye., Bernabeu-Andreu FA; Servicio Bioquímica Análisis Clínicos, Hospital Universitario Puerta de Hierro Majadahonda (Madrid), Majadahonda, Spain., Thelen M; Result Laboratory for Clinical Chemistry, Amphia Hospital, Breda, The Netherlands.; Department of Laboratory Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands., Jacobs LHJ; Laboratory for Clinical Chemistry and Hematology, Meander Medical Centre, Amersfoort, The Netherlands., Linko S; Linko Q-Solutions, Helsinki, Finland., Bhattoa HP; Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary., Bossuyt PMM; Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands., Meško Brguljan P; Department of Clinical Chemistry, University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia., Boursier G; Department of Molecular Genetics and Cytogenomics, Rare and Autoinflammatory Diseases Unit, CHU Montpellier, Univ Montpellier, Montpellier, France., Cobbaert CM; Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, Leiden, The Netherlands., Neumaier M; Institute for Clinical Chemistry, Medical Faculty Mannheim of Heidelberg University, Mannheim, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2023 Jan 31; Vol. 61 (4), pp. 608-626. Date of Electronic Publication: 2023 Jan 31 (Print Publication: 2023). |
| DOI: | 10.1515/cclm-2023-0045 |
| Abstrakt: | The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks. (© 2023 Walter de Gruyter GmbH, Berlin/Boston.) |
| Databáze: | MEDLINE |
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