Risk assessment
The Federal Institute for Drugs and Medical Devices (BfArM) provides information about risks arising from the use or the application of medical devices and the measures appropriate for protection against risks. The information is addressed to the public, health professionals, manufacturers as well as to authorities and complements the advisory notice of the manufacturer and the exchange of written information between authorities.
According to the provisions of the Act on Medical Devices (MPG) and the German Safety Plan for Medical Devices (MPSV), the BfArM is responsible for collecting, analysing and evaluating risks of medical devices and, in so far, co-ordinates the necessary measures to be taken. Any regulatory measures are decided exclusively by the authorities of the German "Laender" responsible for medical devices.
Important note: The publication of information on risks does not denote that the cases were finally evaluated or that final decisions about regulatory measures have already been taken.
Scientific Review
The Federal Institute performs a regular scientific review of risk assessments carried out in the past. The scientific review contains statistical data, analysis of device failures, the causes and consequences of device failures as well as the analysis of corrective actions. Scientific Reviews are only available in German language:
Wissenschaftliche Aufarbeitung
Contact
Should you have questions regarding the web information, please contact the person named in the advisory notice. Enquiries to the Federal Institute should be addressed to:
Federal Institute for Drugs and Medical Devices
- Medical Devices Division -
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Telefax: +49-(0)228-207-5300
E-mail:
md-vigilance@bfarm.de
Non-active medical devices
Dr. Josef Zündorf
Telephone: +49-(0)228-99-307-3202
In-vitro diagnostics and active medical devices
Dr. Ekkehard Stößlein
Telephone: +49-(0)228-99-307-5384