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

• Access to the list of harmonised standards
• 2017: EU-Regulation on Medical Devices

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)