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).

Incidents and serious adverse events (SAE) in clinical trials with medical devices must be notified with the BfArM and/or the PEI according to MPSV Directive (Medical Devices Vigilance - Medizinprodukte-Sicherheitsplanverordnung, MPSV). For further information see the following website: Notification on Incidents and SAE with Medical Devices.

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.

Code Authority Adress Contact
DE/CA99 Federal Institute for Drugs and Medical Devices
(Bundesinstitut für Arzneimittel und Medizinprodukte  - BfArM)
Kurt-Georg-Kiesinger-Allee 3
53175  Bonn
Phone: +49-228-20730
Fax: +49-228-2075207 
E-Mail
http://www.bfarm.de/
DE/CA100 Paul-Ehrlich-Institute (PEI)
Federal Institute for Vaccines and Biomedicines
Paul-Ehrlich-Str. 51-59
63225  Langen
Phone: +49-6103-773114 
Fax: +49-6103-771268
E-Mail
http://www.pei.de