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<p>Sleep watches and sleep trackers are not medical devices within the meaning of medical device law if the manufacturer excludes their use for medical purposes with sufficient clarity without acting arbitrarily. There is no use for medical purposes within the meaning of medical device law if data is exclusively collected, archived and/or compressed or if there is only a&#xa0;pure search or lookup function without interpretation of the data.</p>

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Schlafuhr bzw. Schlaftracker als Medizinprodukt

  • 期刊论文

  • 发表日期：

    2026年7月29日

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  • Reinhard Resch

摘要

Sleep watches and sleep trackers are not medical devices within the meaning of medical device law if the manufacturer excludes their use for medical purposes with sufficient clarity without acting arbitrarily. There is no use for medical purposes within the meaning of medical device law if data is exclusively collected, archived and/or compressed or if there is only a pure search or lookup function without interpretation of the data.