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- Title
AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR.
- Authors
Vogeser, Michael; Brüggemann, Monika; Stenzinger, Albrecht
- Abstract
The document titled "AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR" discusses the implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the European Union. The AWMF (Association of the Scientific Medical Societies in Germany) emphasizes the need for a clear distinction between in-house manufactured IVD devices and medical examination procedures in laboratory diagnostics and pathology. They argue that examination procedures in diagnostics should not be considered as in vitro diagnostic medical devices and should not be subject to European regulation as medical services. The AWMF also opposes any standardization plans that affect medical activity on a national level.
- Subjects
EUROPEAN Union; PATHOLOGICAL laboratories; MEDICAL laboratories; MEDICAL societies; CLINICAL pathology
- Publication
Clinical Chemistry & Laboratory Medicine, 2024, Vol 62, Issue 8, pe173
- ISSN
1434-6621
- Publication type
Letter
- DOI
10.1515/cclm-2024-0254