From the magazine LSR 2/2020 | S. 73-85 The following page is 73

«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 legal risks for the hospitals concerned, and their implementation would pose considerable challenges in legal and practical terms. As a result, they do not appear favorable, especially given the revised regulatory framework for medical devices in Switzerland and the EU.
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