A European Sample Clauses

A European. “qualifying certificate” for the use of surgical robots As said in the previous paragraph, the MDD already allows a strict control on safety and performance of surgical robots. Indeed, European law allows both the MS and the European Commission to adopt significant measures through a specific procedure – eventually leading to the prohibition of further distribution onto the market and the retrieval of devices already released – if a device, after obtaining the CE marking, is still deemed capable of compromising the health and/or the safety of patients, users or other person. An aspect that was instead so far completely neglected by European law is the one of the technical training and requirements of surgeons operating with the device. In fact, in robotics ‘there are no innocent bystanders and the people involved can be given special training to prepare them to use the robotic system optimally. The human actor retains responsibility in this context’ (Xxxxxx, 2014: 83). Indeed, at present, surgical robots are regarded by the law as any other medical device employed in surgical operations, and their usability is only subordinated to the maintenance of the objective conditions required to keep the CE marking. However, to treat surgical robots as a simple medical device tends to be misleading, for it puts the robot on an equal footing with other surgical instruments which are medical devices as well, but much less complex and sophisticated (for example, a stapler or a scissor are also medical devices, which in spite of their possible technical evolutions, still maintain the same function). In fact, the MDD only regulates the function, design and construction requirements of devices, and does not address the opportunities and risks involved in the computer-assisted surgery, among which the subjective qualifications of practitioners called to use it. The most relevant differences which distinguish robot-assisted surgery from open surgery and traditional laparoscopic surgery were presented above. The need to acquire familiarity with the surgeon’s console (i.e. with the display, the interface and the electronic controller) and with the movement of the four slave manipulators, the enhancement provided by the seven degrees of freedom given by the robot are innovative and extraordinary factors, which certainly require adequate training and preparation on the side of the surgeon in order to be fully – and safely – exploited. This remark leads to suggest to adopt a Eur...