This software is designed to let healthcare professionals and interested individuals explore a pageset for use on an AAC device.
It is NOT an AAC device. AAC devices (including software released freely) must be registered as medical devices within the EU. A freely downloadable piece of AAC software must also comply with the relevant medical device legislation in any of the 100s of countries they it can be accessed in.
Software that has a medical purpose could be a medical device. A medical device is defined in the Medical Device Directive (MDD) as software intended by the manufacturer to be used 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
- be very clear that the software was only licence in the EU,
- actively block (presumably by ip filtering) users from other countries