In May 2017, the European In Vitro Diagnostic Regulation (IVDR) entered into force and will apply to in vitro diagnostics from May 26th, 2022. This will have a major impact on the in vitro diagnostics (IVD) industry as all devices falling under the scope of the IVDR will require new or re-certification. It will also affect health institutions developing and using in-house devices. The IVDR also has implications with respect to product performance validation and verification including the pre-analytics of biological samples used by IVD developers and diagnostic service providers. In parallel to the IVDR, a series of standards on pre-analytical sample processing has been published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). These standards describe pre-analytical requirements for various types of analyses in various types of biospecimens. They are of relevance for IVD product developers in the context of (re)certification under the IVDR and to some extent also to devices manufactured and used only within health institutions. This review highlights the background and the rational for the pre-analytical standards. It describes the procedure that leads to these standards, the major implications of the standards and the requirements on pre-analytical workflows. In addition, it discusses the relationship between the standards and the IVDR.

中文翻译：

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医疗诊断中的预分析过程：新的监管要求和标准

2017 年 5 月，欧洲体外诊断法规 (IVDR) 生效，并将于 2022 年 5 月 26 日起适用于体外诊断。这将对体外诊断 (IVD) 行业产生重大影响，因为所有设备都属于IVDR 的范围将需要新的或重新认证。它还将影响开发和使用内部设备的卫生机构。IVDR 还涉及产品性能验证和验证，包括 IVD 开发人员和诊断服务提供商使用的生物样本的预分析。与 IVDR 并行的是，国际标准化组织 (ISO) 和欧洲标准化委员会 (CEN) 发布了一系列关于分析前样品处理的标准。这些标准描述了各种类型生物样本中各种类型分析的预分析要求。它们在 IVDR 下（重新）认证的背景下与 IVD 产品开发人员相关，并且在某种程度上也与仅在卫生机构内制造和使用的设备相关。这篇综述强调了分析前标准的背景和理由。它描述了导致这些标准的程序、标准的主要含义以及对分析前工作流程的要求。此外，它还讨论了标准与 IVDR 之间的关系。它们在 IVDR 下（重新）认证的背景下与 IVD 产品开发人员相关，并且在某种程度上也与仅在卫生机构内制造和使用的设备相关。这篇综述强调了分析前标准的背景和理由。它描述了导致这些标准的程序、标准的主要含义以及对分析前工作流程的要求。此外，它还讨论了标准与 IVDR 之间的关系。它们在 IVDR 下（重新）认证的背景下与 IVD 产品开发人员相关，并且在某种程度上也与仅在卫生机构内制造和使用的设备相关。这篇综述强调了分析前标准的背景和理由。它描述了导致这些标准的程序、标准的主要含义以及对分析前工作流程的要求。此外，它还讨论了标准与 IVDR 之间的关系。