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Perhaps one of the most obvious differences between some CEDs (e.g., the foc. us device)11 and medical devices is their appearance. However, the fact that two devices differ in appearance is clearly not an adequate basis for claiming that the two devices should be subject to different legislation. Devices might differ in color, shape, and style and yet still be functionally equivalent.

Mechanisms and Structure

The mechanisms of action of CEDs and comparable medical devices are essentially the same. tDCS involves placing two or more electrodes on the scalp and passing electrical currents though the skull to alter spontaneous neuronal activity. Although the strength of the electrical currents delivered by different devices may not always be the same, and although the size and position of the electrodes may vary, the underlying principles and effects on the brain are the same. Variation in the structural configuration of different devices does not result in devices of different kinds in any meaningful sense. The structural differences between different devices sold for tDCS research will be as great as the differences between research devices and tDCS devices marketed for enhancement.

If a device with putative enhancement effects were to appear on the market without an obvious medical comparator, then the argument based on mechanistic similarity might be more difficult to maintain. In such a scenario (which seems unlikely), we should first delineate the features that demarcate a device as a “medical device” and establish whether the “enhancement device” shares similar features. The definition of a medical device in the UE is as follows:

Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • • investigation, replacement or modification of the anatomy or of a physiological process,
  • • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.6:5-6

It is unlikely that any device could plausibly make claims to enhance cognition without modifying physiological processes in the brain; in terms of what CEDs do, they have much in common with medical devices. However, a potentially relevant difference is that that CEDs are not intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes. Indeed, it is this feature of the definition that currently prevents CEDs from falling within the remit of the directive. Accordingly, the argument could be made that CEDs and medical devices are not of the same kind because they are used for a different purpose.

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