Competent authorities for applications for the approval of clinical investigations/performance evaluations

Clinical investigations for medical devices and performance evaluations of in vitro diagnostic agents in Germany must be approved by the competent authority (BfArM or PEI) and approvingly evaluated by an Ethics Committee before they may commence (according to §§ 22 and 22a MPG).

The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for clinical investigations of medical devices and for performance evaluations of in vitro diagnostic agents, with the exception of those for which the Paul-Ehrlich-Institute is responsible. The Paul-Ehrlich-Institute (PEI) is responsible for performance evaluations of high risk in vitro diagnostic agents.