Links

Authorities and Organizations

BfArM: Federal Institute for Drugs and Medical Devices

DIN: German Institute for Standardization

DIN Media: DIN Media

ISO: International Organisation for Standardization

Paul Ehrlich Institute: Federal Institute for Vaccines and Biomedicines

ZLG: Central Office of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices

IG-NB: Association of Notified Bodies

Research

Department of Medical Technology at TU Berlin

Medical Technology Department

Laws and Guidelines

EU-Regulations

Laws (Please note that the national laws are only available in German!)

MPBetreibV (Medical Device Operators Ordinance)
MPDG (Act on the Implementation of Union Regulations on Medical Devices)
MPSV (Ordinance on the identification, assessment and defence against risks associated with medical devices
Medical Device Safety Plan Ordinance)
MPAV (Ordinance regulating the supply of Medical Devices)