In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency-Reference-Cited by-同舟云学术

In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Published:2023-07-27 Issue:1 Volume:62 Page:e1-e3
ISSN:1434-6621
Container-title:Clinical Chemistry and Laboratory Medicine (CCLM)
language:en
Short-container-title:

Author:

Vanstapel Florent J.L.A.¹²^ORCID,Boursier Guilaine³^ORCID,Cobbaert Christa M.⁴^ORCID

Affiliation:

1. Laboratory Medicine , University Hospital Leuven , Leuven , Belgium

2. Department of Public Health, Biomedical Sciences Group , Catholic University Leuven , Leuven , Belgium

3. Department of Molecular Genetics and Cytogenomics, Rare Diseases and Autoinflammatory Unit , CHU Montpellier, Univ Montpellier , Montpellier , France

4. Department of Clinical Chemistry and Laboratory Medicine , Leiden University Medical Centre , Leiden , The Netherlands

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

Link

https://www.degruyter.com/document/doi/10.1515/cclm-2023-0750/pdf

Reference10 articles.

1. European Parliament and Council. Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices. Off J Eur Union 2017;117:176–332.

2. Medical Device Coordination Group. MDCG 2023-1 Guidance on the health institution exemption under article 5(5) of the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf [Accessed 12 Jan 2023].

3. Vanstapel, FJLA, Orth, M, Streichert, T, Capoluongo, ED, Oosterhuis, WP, Çubukçu, HC, et al.. 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. Joint opinion of task force on European regulatory affairs and working group accreditation and ISO/CEN standards of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2023;61:608–26. https://doi.org/10.1515/cclm-2023-0045.

4. Vogeser, M, Brüggemann, M. Complex analytical procedures in diagnostic laboratories and the IVDR. Clin Chem Lab Med 2020;59:1175. https://doi.org/10.1515/cclm-2020-1775.

5. Plenipotentiaries. Treaty on the functioning of the European union. Off J Eur Union 2016;C202/1:47–366.

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