Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 69120, Heidelberg, Germany.
Faculty of Law, University of Augsburg, Augsburg, Germany.
Pathologie (Heidelb). 2023 Nov;44(Suppl 2):86-95. doi: 10.1007/s00292-023-01274-6. Epub 2023 Dec 4.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) imposes several conditions on pathology departments that develop and use in-house in vitro diagnostic medical devices (IH-IVDs). However, not all of these conditions need to be implemented immediately after the IVDR entered into force on 26 May 2022. Based on an amending regulation of the European Parliament and the Council of the European Union, the requirements for IH-IVDs will be phased in. Conformity with the essential safety and performance requirements of annex I must be ensured from May 2022.
With this article, we would like to present the practical implementation of the currently valid conditions for IH-IVDs at the Institute of Pathology at the University Hospital of Heidelberg, in order to provide possible assistance to other institutions.
In addition to the intensive work on the requirements for IH-IVDs, several guidance documents and handouts provide orientation for the implementation and harmonisation of the requirements for healthcare institutions mentioned in Article 5 (5). Exchange in academic network structures is also of great importance for the interpretation and practical implementation of the IVDR. For university and nonuniversity institutions, ensuring conformity with the IVDR represents a further challenge in terms of personnel and time, in addition to the essential tasks of patient care, teaching and research and the further development of methods for optimal and targeted diagnostics, as well as the maintenance of the constantly evolving quality management system.
体外诊断医疗器械法规（EU）2017/746 对开发和使用内部体外诊断医疗器械（IH-IVD）的病理科提出了若干条件。然而，并非所有这些条件都需要在 2022 年 5 月 26 日法规（EU）2017/746 生效后立即实施。根据欧洲议会和欧盟理事会的一项修订法规，对 IH-IVD 的要求将分阶段实施。自 2022 年 5 月起，必须确保符合附件 I 的基本安全和性能要求。
本文旨在展示海德堡大学医院病理学研究所目前对 IH-IVD 的有效条件的实际实施情况，以便为其他机构提供可能的帮助。
除了 IH-IVD 的要求的密集工作外，还为 Article 5 (5) 中提到的医疗保健机构的要求的实施和协调提供了几份指导文件和说明。学术网络结构的交流对于法规（EU）2017/746 的解释和实际实施也非常重要。对于大学和非大学机构来说，除了患者护理、教学和研究的基本任务以及进一步开发最佳和有针对性的诊断方法以及不断发展的质量管理体系的维护之外，确保符合法规（EU）2017/746 还代表着人员和时间方面的进一步挑战。
