„A digital twin is defined as a computer-protected model of a martyred or immaterial object that can be used for a specific purpose. This can be processes, products or services that connect the real and virtual worlds. There are always three elements, the real object to be depicted, the digital twin in virtual space, which can also be a virtual image of the patient in medicine, and the flow of information that connects the two parts. Thus, medical device manufacturers can succeed in subjecting a product development as a Digital Twin to a safety and performance test to achieve a faultless and safe design of a medical device in this way. Among other things, this saves medical device manufacturers cost-intensive test phases and reduces the number of clinical studies. However, it is also possible to simulate a digital twin as a patient, for example, to combine both, i.e. virtual image of the patient and virtual image of the medical device, to adapt the product development process individually to the characteristics and needs of each patient and his or her medical history, which is still a dream of the future. The medical device manufacturer has the possibility of an exclusion of liability through information and data collection. However, this also affects the patient’s rights to data security and sovereignty. In this way, the development of the production of a medical device can also be examined in advance for liability risks so that manufacturers are on the legally secure side. The manufacturer also has production monitoring obligations and must also invest in maintenance measures for the medical products. He is also responsible for monitoring the interaction with competing products. Tests of the consequences of a treatment, when the virtual image of a medical device meets the virtual image of an individual, in this case the patient, allow a relatively secure statement. Legal considerations regarding product liability in the medical technology sector and increased requirements for market observation can be better realized with the help of the digital twin.
