Ethics Committees
In Germany, the clinical investigation of a medical device or performance study of an in vitro diagnostic device may only begin once it has been approvingly evaluated by the competent Ethics Committee, and it has been approved by the competent authority (BfArM or PEI).
The affirmative evaluation from the Ethics Committee as required by MDR or IVDR in conjunction with MPDG must be requested by the sponsor from the independent interdisciplinary Ethics Committee that is responsible for the investigator according to federal state law. The duty of the Ethics Committee is to verify the study plan and the required documents, particularly from ethical and legal points of view, and to check if the legal requirements are fulfilled.