«Zulassung» von Medizinprodukten durch Spitäler?
Hintergrund, Einordnung und Risiken entsprechender Konzepte
- Keywords: Heilmittel, Medizinprodukte, Haftung, MDR, Konformitätsbewertung
Abstract
In the aftermath of the “Implant Files” media coverage, a Swiss group of private hospitals considered to introduce a system of “approval” for medical devices, meaning that only devices that pass an own assessment would be permitted to be used within the relevant hospital group. However, such systems would create significant…[…]