Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Deutschland.
Chemisches und Veterinäruntersuchungsamt Freiburg, Deutschland (1989 - 2020), EU-Referenzlaboratorium für Dioxine und PCB in Lebensmitteln und Futtermitteln, Freiburg, Deutschland.
Klin Monbl Augenheilkd. 2022 Jul;239(7):905-912. doi: 10.1055/a-1863-9331. Epub 2022 May 30.
The European Commission revised Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) to improve patient safety and take appropriate account of technical progress. With the new Regulation (EU) 2017/746 of April 5, 2017 on in vitro diagnostic medical devices (IVDR), high standards for the quality and safety of in vitro diagnostic medical devices (IVD) apply within the European Union. The IVDR is primarily aimed at manufacturers and suppliers of IVDs, but also has significant implications for medical diagnostic laboratories. Its application is mandatory as of May 26, 2022. IVD are classified into four risk classes A to D according to their intended purpose and the associated risks. For the first time, EU-wide legal requirements are formulated for products manufactured in-house. Any medical laboratory that uses "laboratory-developed tests" (LDT), or modifies or uses CE-IVD products outside the manufacturer's specifications, becomes a manufacturer itself and IVDR Article 5 (5) applies in its entirety. Production and use of LDT must then be performed within the framework of appropriate QM systems. The health care facility must comply with certain provisions (standards), in Germany the Rili-BÄK is to be mentioned here. LDT are subject to the safety and performance requirements listed in Annex 1 to the IVDR, including the requirement for validation prior to first use, while commercial CE-IVD products only require verification. Regulation (EU) 2022/112 of January 25, 2022, provides for staggered transition periods of up to six years for some of these requirements, but it is expected that many laboratories will switch from LDT to commercial CE-marked IVD products because ultimately this will be more resource-efficient for them. In this article, we describe the requirements for medical diagnostic laboratories resulting from the IVDR and offer solution concepts for their implementation in smaller, especially ophthalmopathology laboratories.
欧盟委员会修订了关于体外诊断医疗器械（IVDD）的 98/79/EC 指令，以提高患者安全性并适当考虑技术进步。随着 2017 年 4 月 5 日关于体外诊断医疗器械（IVDR）的新法规（EU）2017/746 的实施，欧盟内部对体外诊断医疗器械（IVD）的质量和安全设定了高标准。IVDR 主要针对 IVD 的制造商和供应商，但对医学诊断实验室也有重大影响。自 2022 年 5 月 26 日起，该法规的应用具有强制性。根据预期用途和相关风险，IVD 被分为 A 至 D 四个风险类别。欧盟首次为内部制造的产品制定了统一的法律要求。任何使用“实验室开发的测试”（LDT）或修改或超出制造商规格使用 CE-IVD 产品的医学实验室本身都会成为制造商，并且 IVDR 第 5（5）条将全部适用。然后，必须在适当的 QM 系统框架内进行 LDT 的生产和使用。医疗机构必须遵守某些规定（标准），这里要提到德国的 Rili-BÄK。LDT 必须符合 IVDR 附件 1 中列出的安全和性能要求，包括首次使用前的验证要求，而商业 CE-IVD 产品只需验证。2022 年 1 月 25 日的法规（EU）2022/112 为其中一些要求提供了长达六年的交错过渡期，但预计许多实验室将从 LDT 过渡到商业 CE 标记的 IVD 产品，因为最终这对他们来说更具资源效益。在本文中，我们描述了 IVDR 对医学诊断实验室的要求，并为其在较小的、特别是眼科病理学实验室中的实施提供了解决方案概念。
