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In view of increasing complexity and costs involved in bringing medical devices to market, the question might arise as to why there is a need for such a level of control and regulation. The answer is clear: Regulation is crucial to ensure that medical devices are of high quality and thus safe and effective. The safety and effectiveness of medical devices are essential for the health of patients and the overall functioning of the global healthcare system. Strict control is necessary to enforce regulations in order to protect patients and users as well as manufacturers. At the same time, regulatory mechanisms always face the challenge not to restrict the industry’s ability to innovate and compete beyond a reasonable level.

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The Need for Effective Regulation of Medical Devices

  • 章节

  • 出版模式：

    开放获取

  • 发表日期：

    2026年

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  • Cosimo Franco,
  • Ellen Thom,
  • Andreas Krämer

摘要

In view of increasing complexity and costs involved in bringing medical devices to market, the question might arise as to why there is a need for such a level of control and regulation. The answer is clear: Regulation is crucial to ensure that medical devices are of high quality and thus safe and effective. The safety and effectiveness of medical devices are essential for the health of patients and the overall functioning of the global healthcare system. Strict control is necessary to enforce regulations in order to protect patients and users as well as manufacturers. At the same time, regulatory mechanisms always face the challenge not to restrict the industry’s ability to innovate and compete beyond a reasonable level.