From: Moritz v. Buttlar (info_at_baltic-microsolutions.de)
Date: 2001-06-08 09:31:50
Hi !
If we say our device is a biofeedback device for improving concentration (not
for curing diseases) then it isnīt a medical device (at least in Germany, if I
interpret the law on medical devices right). So we could say our device is for
ordinary people who want to improve their concentration and meditation skills.
Maybe there are still product liability issues, but it would at least spare us
all the problems associated with special certification needed for medical
equipment.
Maybe somebody could check on all the other biofeedback equipment: what kind of
certification do they claim for their devices ? Do they call it a medical device
and if not how do they call it ?
Thatīs also the reason why I didnīt want to call it openly an EEG device. This
name could confuse people to use our device like an EEG and use it for
declaring somebody braindead (in the worst case). If we call it EEG, we canīt
say itīs not a medical device and it doesnīt need certification. There are also
lots of rules especially about medical measurement devices regarding
calibration and so on. To avoid confusion about the goal our device was
designed for, we should maybe not use the term EEG.
I like the idea of forming some kind of NGO very much.
Moritz
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