It may meet self-certification, if determined class I level, under the EU medical device guidelines. The EU defines and distinguishes class II largely along issues of invasiveness, but also on issues of energy exposure, in terms of having an altering biochemical effect, and that would have to be minimal in the case of the Bioharp. Lower level radiation (electromagnetic) devices can fall under class I under the EU (European Commission), which may be different than FDA. It distinguishes whether having a monitoring function for such devices, which would entail longer exposure to an electrical source, in classifying for different levels. I don't see this level of radiation ( a simple battery source) inducing biochemical response by raising or changing it to produce even a modest level of threat.
The EU is the second largest medical device market, at around 30% of the worldwide market.
Normally class II devices under FDA don't require clinical trials, but since the Bioharp may not have a precursor technology which it can cite, it likely requires them, though the standard for clinical trial results is likely lower than for class III devices.
I've never viewed these medical approvals as a major hurdle. I view clinical trials much more important for acceptance within the medical community.
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