Figure 1
a: In pathology, process chains in analytics for which physicians are responsible lead to valid findings and thus to a diagnosis and optimal patient care.
b: Definitions of “in vitro diagnostic medical device” and “medical device” according to the two regulations (EU) 2017/745 (MDR) [18] and 2017/746 (IVDR) [17]
c: According to the definitions of the IVDR and MDR, in vitro diagnostic medical devices are a subset of medical devices.