“BREATHMENT” Wellness app or a Medical Device
Overview of the classification variety
The following table can serve as a rough orientation of the classification using the example of different pulse measuring functionalities. These tables provide only an exemplary overview. Exact classification may vary by the exact definition of the intended use as discussed later in this paper.
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Please note that a new version of the “MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under
Regulation (EU) 2017/745 on medical devices” was published after the press deadline.
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