https://glursignal.com/index.p....hp/influence-involvi
The laws surrounding the introduction and use of medical AI devices in the European Union (EU) are different to those in the USA, plus the specifics of European legislature in medical AI aren't commonly known. European law categorizes health products into four classes we, IIa, IIb, and III, depending on the observed danger standard of these devices. Medical products tend to be certified under independent nongovernment bodies, and some can even self-certify their particular compliance with EU standards