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This chapter deals with the specific legal framework, classification, and performance requirements for in vitro diagnostic medical devices (IVDs) under the EU IVD Regulation (EU) 2017/746 and highlights their special role compared to general medical devices, which are subject to the MDR. It outlines the key differences between the assessment approaches—performance evaluation for IVDs versus clinical evaluation for general products—and the implications of the risk-based classification system of the IVD Regulation. The chapter also clarifies when diagnostic software is considered to be IVD software and discusses the strategic importance of early performance evaluation planning. Manufacturers are provided with practical guidance on the conformity assessment and regulatory planning. Furthermore, trends and challenges such as digitalization, AI-based diagnostics, companion diagnostics, and the impact of global regulatory differences are highlighted.

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In Vitro Diagnostic (IVD) Devices: Crucial in Diagnosing and Monitoring

  • 章节

  • 出版模式：

    开放获取

  • 发表日期：

    2026年

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  • Peter Hartung,
  • Kirsten Theiling

摘要

This chapter deals with the specific legal framework, classification, and performance requirements for in vitro diagnostic medical devices (IVDs) under the EU IVD Regulation (EU) 2017/746 and highlights their special role compared to general medical devices, which are subject to the MDR. It outlines the key differences between the assessment approaches—performance evaluation for IVDs versus clinical evaluation for general products—and the implications of the risk-based classification system of the IVD Regulation. The chapter also clarifies when diagnostic software is considered to be IVD software and discusses the strategic importance of early performance evaluation planning. Manufacturers are provided with practical guidance on the conformity assessment and regulatory planning. Furthermore, trends and challenges such as digitalization, AI-based diagnostics, companion diagnostics, and the impact of global regulatory differences are highlighted.