Regulation of Medical Robots in Switzerland: The Example of Robotic Applications in Minimally Invasive Surgery

The use of robotic applications is a growing trend in Switzerland’s healthcare sector. For example, robots have been broadly in use in minimally invasive surgery. Robotic applications in minimally invasive surgery are an information-driven and safety-critical technology governed, amongst others, by data protection as well as medical device regulations. Doctors must make sure they understand how such robots process patient-specific information to comply with the relevant provisions of data protection regulations, which include, in the opinion of the authors, the requirement to seek informed patient consent. Robotic applications in minimally invasive surgery are (normally) medical devices under Swiss law. In this respect, the revised Therapeutic Product Act leads to a tightening of medical device regulations and an increase of the barriers to market entry for medical device manufacturers.