Are EMOTIV products medical devices?
EMOTIV Inc does not make any representations about the efficacy of any treatment or diagnostic method based on EEG data derived from EPOC, EPOC+, Insight or EPOC FLEX headsets. EMOTIV products are intended to be used for research applications and personal use only. Our products are not sold as Medical Devices as defined in EU directive 93/42/EEC.
EMOTIV products hold CE and other regulatory approvals, which means it has been assessed by independent bodies for safety. We comply with all international product safety standards including radio frequency emissions and electrical safety, as well as other issues such as possibly toxicity or allergic reactions to components. Our products are perfectly safe and harmless to users.
Our products are fully certified for safety and wireless interference standards in Europe, Australia and North America and they are fully CE-marked. These standards are recognised world wide.
Here you can find EMOTIV information on compliance with regulatory requirements:
EPOC Flex Regulatory Compliance