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)
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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; AWMF Ad hoc Commision In-vitro Diagnostic Medical Devices.
In: Ger Med Sci, Vol. 19, 2021, p. Doc08.Research output: SCORING: Contribution to journal › Other (editorial matter etc.) › Research
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T1 - 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)
AU - Hoffmüller, Petra
AU - Brüggemann, Monika
AU - Eggermann, Thomas
AU - Ghoreschi, Kamran
AU - Haase, Detlef
AU - Hofmann, Jörg
AU - Hunfeld, Klaus-Peter
AU - Koch, Katharina
AU - Meisel, Christian
AU - Michl, Patrick
AU - Müller, Jens
AU - Müller, Carsten
AU - Rabenau, Holger F
AU - Reinhardt, Dirk
AU - Riemenschneider, Markus J
AU - Sachs, Ulrich J
AU - Sack, Ulrich
AU - Stenzinger, Albrecht
AU - Streichert, Thomas
AU - von Neuhoff, Nils
AU - Weichert, Wilko
AU - Weinstock, Christof
AU - Zimmermann, Stefan
AU - Spitzenberger, Folker
AU - AWMF Ad hoc Commision In-vitro Diagnostic Medical Devices
N1 - Copyright © 2021 Hoffmüller et al.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
U2 - 10.3205/000295
DO - 10.3205/000295
M3 - Other (editorial matter etc.)
C2 - 34194291
VL - 19
SP - Doc08
JO - Ger Med Sci
JF - Ger Med Sci
SN - 1612-3174
ER -
