Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)

In view of the approaching application date of Regulation (EU) 2017/746 („IVDR“) and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scie...

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Autores principales: Hoffmüller, Petra, Brüggemann, Monika, Eggermann, Thomas, Ghoreschi, Kamran, Haase, Detlef, Hofmann, Jörg, Hunfeld, Klaus-Peter, Koch, Katharina, Meisel, Christian, Michl, Patrick, Müller, Jens, Müller, Carsten, Rabenau, Holger F., Reinhardt, Dirk, Riemenschneider, Markus J., Sachs, Ulrich J., Sack, Ulrich, Stenzinger, Albrecht, Streichert, Thomas, von Neuhoff, Nils, Weichert, Wilko, Weinstock, Christof, Zimmermann, Stefan, Spitzenberger, Folker
Formato: Online Artículo Texto
Lenguaje:English
Publicado: German Medical Science GMS Publishing House 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204380/
https://www.ncbi.nlm.nih.gov/pubmed/34194291
http://dx.doi.org/10.3205/000295
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author Hoffmüller, Petra
Brüggemann, Monika
Eggermann, Thomas
Ghoreschi, Kamran
Haase, Detlef
Hofmann, Jörg
Hunfeld, Klaus-Peter
Koch, Katharina
Meisel, Christian
Michl, Patrick
Müller, Jens
Müller, Carsten
Rabenau, Holger F.
Reinhardt, Dirk
Riemenschneider, Markus J.
Sachs, Ulrich J.
Sack, Ulrich
Stenzinger, Albrecht
Streichert, Thomas
von Neuhoff, Nils
Weichert, Wilko
Weinstock, Christof
Zimmermann, Stefan
Spitzenberger, Folker
author_facet Hoffmüller, Petra
Brüggemann, Monika
Eggermann, Thomas
Ghoreschi, Kamran
Haase, Detlef
Hofmann, Jörg
Hunfeld, Klaus-Peter
Koch, Katharina
Meisel, Christian
Michl, Patrick
Müller, Jens
Müller, Carsten
Rabenau, Holger F.
Reinhardt, Dirk
Riemenschneider, Markus J.
Sachs, Ulrich J.
Sack, Ulrich
Stenzinger, Albrecht
Streichert, Thomas
von Neuhoff, Nils
Weichert, Wilko
Weinstock, Christof
Zimmermann, Stefan
Spitzenberger, Folker
author_sort Hoffmüller, Petra
collection PubMed
description In view of the approaching application date of Regulation (EU) 2017/746 („IVDR“) and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scientific Medical Societies (AWMF) takes a national position on the details of the requirements and conditions related to the use of these IVD products. The Ad hoc Commission IVD emphasizes the relevance of examination procedures developed in medical laboratories, especially in the field of orphan diseases and new diagnostic markers. The IVDR sets an adequate regulatory framework for IVD manufactured and used within health institutions as long as these requirements are fulfilled with reliability and in accordance with the current state of the art in medical laboratory sciences. At the same time, the IVDR requirements have to be regarded under a pragmatic view and in accordance with the quality management systems approved within the different EU Member States. On the one hand, the mandatory requirements of the RiLiBÄK play an essential role in Germany. On the other hand, elements of voluntarily applicable international standards may support the fulfilment of product requirements for safety and performance according to Annex I of the IVDR. Both the complexity and possible solutions for the implementation of the IVDR requirements are discussed on the basis of examples such as the required documentation, performance evaluation and software validation. The Ad hoc Commission IVD recommends that, while aiming at a preferably EU-wide harmonized interpretation of the IVDR requirements, the flexibility in medical laboratory diagnostics necessary for patient care, including the use of IVD from in-house production, should be emphasized.
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spelling pubmed-82043802021-06-29 Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) Hoffmüller, Petra Brüggemann, Monika Eggermann, Thomas Ghoreschi, Kamran Haase, Detlef Hofmann, Jörg Hunfeld, Klaus-Peter Koch, Katharina Meisel, Christian Michl, Patrick Müller, Jens Müller, Carsten Rabenau, Holger F. Reinhardt, Dirk Riemenschneider, Markus J. Sachs, Ulrich J. Sack, Ulrich Stenzinger, Albrecht Streichert, Thomas von Neuhoff, Nils Weichert, Wilko Weinstock, Christof Zimmermann, Stefan Spitzenberger, Folker Ger Med Sci Article In view of the approaching application date of Regulation (EU) 2017/746 („IVDR“) and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scientific Medical Societies (AWMF) takes a national position on the details of the requirements and conditions related to the use of these IVD products. The Ad hoc Commission IVD emphasizes the relevance of examination procedures developed in medical laboratories, especially in the field of orphan diseases and new diagnostic markers. The IVDR sets an adequate regulatory framework for IVD manufactured and used within health institutions as long as these requirements are fulfilled with reliability and in accordance with the current state of the art in medical laboratory sciences. At the same time, the IVDR requirements have to be regarded under a pragmatic view and in accordance with the quality management systems approved within the different EU Member States. On the one hand, the mandatory requirements of the RiLiBÄK play an essential role in Germany. On the other hand, elements of voluntarily applicable international standards may support the fulfilment of product requirements for safety and performance according to Annex I of the IVDR. Both the complexity and possible solutions for the implementation of the IVDR requirements are discussed on the basis of examples such as the required documentation, performance evaluation and software validation. The Ad hoc Commission IVD recommends that, while aiming at a preferably EU-wide harmonized interpretation of the IVDR requirements, the flexibility in medical laboratory diagnostics necessary for patient care, including the use of IVD from in-house production, should be emphasized. German Medical Science GMS Publishing House 2021-06-01 /pmc/articles/PMC8204380/ /pubmed/34194291 http://dx.doi.org/10.3205/000295 Text en Copyright © 2021 Hoffmüller et al. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Hoffmüller, Petra
Brüggemann, Monika
Eggermann, Thomas
Ghoreschi, Kamran
Haase, Detlef
Hofmann, Jörg
Hunfeld, Klaus-Peter
Koch, Katharina
Meisel, Christian
Michl, Patrick
Müller, Jens
Müller, Carsten
Rabenau, Holger F.
Reinhardt, Dirk
Riemenschneider, Markus J.
Sachs, Ulrich J.
Sack, Ulrich
Stenzinger, Albrecht
Streichert, Thomas
von Neuhoff, Nils
Weichert, Wilko
Weinstock, Christof
Zimmermann, Stefan
Spitzenberger, Folker
Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)
title Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)
title_full Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)
title_fullStr Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)
title_full_unstemmed Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)
title_short Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)
title_sort advisory opinion of the awmf ad hoc commission in-vitro diagnostic medical devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the union according to regulation (eu) 2017/746 (ivdr)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204380/
https://www.ncbi.nlm.nih.gov/pubmed/34194291
http://dx.doi.org/10.3205/000295
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