«Künstliche Intelligenz» und Medizinprodukte: Qualifizierung und Klassifizierung unter der MDR
Gegenwärtige Situation und mögliche Entwicklungen
- Keywords: Medizinprodukterecht
Abstract
Medical devices involving «Artificial Intelligence» (AI) must, like any other device, comply with the relevant regulatory framework. As far as the MDR is concerned, applying, in particular, the qualification and classification principles and provisions to such devices doubtlessly poses certain challenges. However, these challenges may very well be adequately resolved…[…]
