Kahles Andy, Goldschmid Hannah, Volckmar Anna-Lena, Plöger Carolin, Kazdal Daniel, Penzel Roland, Budczies Jan, Kempny Gisela, Kazmierczak Marlon, Flechtenmacher Christa, Baretton Gustavo, Weichert Wilko, Horst David, Klauschen Frederick, Gassner Ulrich M, Brüggemann Monika, Vogeser Michael, Schirmacher Peter, Stenzinger Albrecht
Pathologisches Institut, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 224, 69120, Heidelberg, Deutschland.
Bundesverband Deutscher Pathologen e. V., Berlin, Deutschland.
Pathologie (Heidelb). 2022 Sep;43(5):351-364. doi: 10.1007/s00292-022-01077-1. Epub 2022 May 19.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-IVDs, in-house IVDs, and RUO products are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities.
Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge.
The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments.
欧盟关于体外诊断医疗器械的第2017/746号法规（IVDR）于2017年4月5日由欧洲议会和欧盟理事会通过，并于2017年5月26日生效。2021年12月15日通过了一项新的修订法规，该法规引入了IVDR的分阶段实施，对某些体外诊断医疗器械有新的过渡条款，并对医疗保健机构内部使用的内部设备的一些要求规定了较晚的适用日期。CE体外诊断医疗器械、内部体外诊断医疗器械和研究用体外诊断产品的联合使用是病理科诊断的基石，对优化患者护理至关重要。IVDR不仅规范了工业生产的体外诊断医疗器械的制造和投放市场，还对医疗保健机构内部使用的内部体外诊断医疗器械的制造和使用提出了条件。
我们的工作概述了IVDR的背景和结构，并确定了在法律框架以及专业知识背景下需要解释和充实的核心领域。
IVDR中的差距和模糊之处迫切需要专业协会、联盟和各利益相关方的专业知识，以成功推动IVDR在病理科的实施和使用，并避免出现异常发展情况。
