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.
|DE/CA99||Federal Institute for Drugs and Medical Devices
(Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM)
Federal Institute for Vaccines and Biomedicines