Hopefully you can help me with a query of mine. I’m currently intersted in purchasing an Embla N7000 EEG/PSG with all relevant software (Sandmand Elite) and hardware. This would be used to perform a private study on multiple areas of sleep phenomena and hopefully capture the events. It would possibly be the longest sleep study of it’s kind.
Although I would consider myself well versed techinically, I don’t actually work in medical care.
Technically the EEG would fall under consumer use.
I wondered if you could help me regarding the legalities of EEG/PSG recording at home, and whether there would be any issues on that front. I undestand that EEG’s generally fall under a medical grey when it comes to medical device regulations.
I have attempted to enquire about this through the United Kingdoms (where I’m based) MHRA (Medicines & Healthcare Products Regulatory Agency) but have yet to garner a response.
Many thanks for any input,