The clinical investigation of a medical device in Germany may only begin once it has been approvingly evaluated by the competent Ethics Committee according to § 22 Medical Devices Act (MPG), and it has been approved by the competent authority (BfArM or PEI) according to § 22a Medical Devices Act (MPG).
The affirmative evaluation from the Ethics Committee as required by § 20 (1) Medical Devices Act (MPG) must be requested by the sponsor from the independent interdisciplinary Ethics Committee who is responsible for the investigator according to federal state law. Full particulars are regulated by § 22 Medical Devices Act (MPG). 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 requirements stated in the Medical Devices Act (MPG) are fulfilled.
You can find address and contact information of the competent Ethics Committees under: