Figure 3
a: Institutes of pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and must fulfil the respective legal requirements depending on their function.
b: Legal framework as an operator and user of in vitro diagnostic medical devices
c: Legal framework as an in-house manufacturer of in vitro diagnostic medical devices
d: Inspection of compliance with medical device law by competent authorities in accordance with the general administrative regulation MPRVwV