a market for hearing aids and implants not at all regulated by FDA/MDR, what could possibly go wrong? /s Easing regulations for non-implant devices could reall

a market for hearing aids and implants not at all regulated by FDA/MDR, what could possibly go wrong? /s Easing regulations for non-implant devices could really shake up the market in a good way, implantables OTOH should always be regulated as medical devices. But certifications with TÜV or similar are really getting out of hand with the new medical device regulation. The amount of paperwork for even pretty simple devices like a remote control is extraordinary. Source: I work for $company in that specific sector