Regulating endorobots in the European Union: An overview of the ethical and legal framework

The most recent innovation in endoscopic medical devices intersects two very diverse main disciplines—robotics and surgery, both promising extraordinary opportunities and raising some concerns for their ethical and legal consequences. In this chapter, we provide a general overview of such issues, focusing on the European Union framework. First, we provide an up-to-date overview of the academic discussion on the social impact of robotics and “roboethics,” the new discipline in applied ethics, and clarifying the fundamental principles of “engineering ethics” that should be taken into consideration in designing and implementing endorobots. Then, we describe the regulatory framework in the EU, illustrating briefly the transition between the current legislation (provided by the combination of Directive 1993/42/EEC and Directive 1990/385/EEC), the new Regulation (EU) 2017/745 (expected to enter into force in 2021), and the proposals of Regulations concerning ethical aspects and legal liability of Artificial Intelligence and robotics adopted by the European Parliament in October 2020.