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Starting from a high level of health protection for patients and users, the present regulation is intended to ensure a smoothly functioning internal market for in vitro diagnostics, taking into account the small- and medium-sized enterprises active in this sector. In addition, this regulation sets high standards for the quality and safety of in vitro diagnostics, which are intended to dispel general safety concerns regarding these products. Excerpt from the preamble of the new regulation (Regulation (EU) 2017a, b /746)

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The New EU Regulation 2017/746 on in vitro Diagnostic Medical Devices

  • 章节

  • 发表日期：

    2026年

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  • Volker Franzen,
  • Thomas Klütz

摘要

Starting from a high level of health protection for patients and users, the present regulation is intended to ensure a smoothly functioning internal market for in vitro diagnostics, taking into account the small- and medium-sized enterprises active in this sector. In addition, this regulation sets high standards for the quality and safety of in vitro diagnostics, which are intended to dispel general safety concerns regarding these products. Excerpt from the preamble of the new regulation (Regulation (EU) 2017a, b /746)