Clinical investigations and performance studies
Tasks
The BfArM is responsible for approving clinical investigations of medical devices in accordance with Regulation (EU) 2017/745 ("Medical Device Regulation", MDR) and for approving performance studies of in vitro diagnostic devices in accordance with Regulation (EU) 2017/746 ("In Vitro Diagnostic Regulation", IVDR).
Laws and ordinances (in German)
Contact point for subjects of a clinical investigation or performance study
The Federal Institute for Drugs and Medical Devices (BfArM) offers a contact point for subjects participating in a clinical investigation of a medical device / performance study of an in vitro diagnostic medical device or their legal representatives in accordance with Article 62(4)(g) of Regulation 2017/745 (MDR) or Article 58(5)(g) of Regulation 2017/746 (IVDR) in conjunction with Section 70 of the German Medical Devices Implementation Act (MPDG).
Contact
Federal Institute for Drugs and Medical Devices
Unit Clinical Investigation with Medical Devices
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Phone: +49-(0)228-207-3975
e-mail:
MPKP-Kontaktstelle@bfarm.de
Please use the contact form for written inquiries and indicate "MPKP contact point" as the subject in the letter or e-mail.