CAContact object
Competent federal higher authority ("Bundesoberbehörde- BOB")
Federal Institute for Drugs and Medical Devices*: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Abteilung Medizinprodukte/ Department Medical Devices
+49-228-20730
+49-228-2075207
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany (DE)
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
Competent federal higher authority ("Bundesoberbehörde- BOB")
Federal Institute for Vaccines and Biomedicine/ Paul-Ehrlich-Institute (PEI)
Paul-Ehrlich-Str. 51-59
63225 Langen
Germany (DE)
The Paul-Ehrlich-Institute (PEI) is responsible for performance evaluations of high risk in vitro diagnostic agents.