Expert opinion within the context of the targeted evaluation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices pursuant to Article 111 and Regulation (EU) 2024/1860
EU laws are usually evaluated after 10 years; in the case of the IVDR, the targeted evaluation was brought forward and stakeholders in laboratory diagnostics were invited to comment. The Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medi...
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| Autores principales: | , , , , , |
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| Formato: | Article (Journal) |
| Lenguaje: | inglés |
| Publicado: |
2026
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| In: |
Clinical chemistry and laboratory medicine
Year: 2026, Volumen: 64, Número: 2, Pages: 280-283 |
| ISSN: | 1437-4331 |
| DOI: | 10.1515/cclm-2025-0941 |
| Acceso en línea: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1515/cclm-2025-0941 Verlag, lizenzpflichtig, Volltext: https://www.degruyterbrill.com/document/doi/10.1515/cclm-2025-0941/html?lang=de 
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| Notas de Autor: | Michael Vogeser, Monika Brüggemann, Ulrich Sack, Christoph Weinstock, Stefan Zimmermann, Albrecht Stenzinger |
| Sumario: | EU laws are usually evaluated after 10 years; in the case of the IVDR, the targeted evaluation was brought forward and stakeholders in laboratory diagnostics were invited to comment. The Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V.), recognises a relevant need to amend the IVDR with regard to in-vitro -diagnostic medical devices that are manufactured and used in healthcare facilities but are not placed on the EU market. Inadequate overregulation is recognised and should be corrected as part of the generally required reduction of bureaucracy. |
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| Notas: | Online veröffentlicht am 1.Oktober 2025 Gesehen am 11.08.2026 |
| Descripción Física: | Online Resource |
| ISSN: | 1437-4331 |
| DOI: | 10.1515/cclm-2025-0941 |