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Information on Risks

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.

To receive more information about the medical devices vigilance system click here.


Field Corrective Actions

Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices and to advise on what action should be taken to protect the health or the safety of patients, users or other persons. For example, advisory notices may contain information from the manufacturer that he is voluntarily recalling a medical device.


BfArM Recommendations

BfArM Recommendations include information about risks arising from medical devices and measures recommended by the Federal Institute in order to reduce or eliminate risks. These recommendations mainly derive from the evaluation of incident reports received under the medical devices vigilance system.


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.


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


Information on Risks provided by Other Competent Authorities

Schweizerisches Heilmittelinstitut (Swissmedic), Switzerland

Agence nationale de sécurité du médicament et des produits de santé (ANSM), France

Medicines and Healthcare Products Regulatory Agency (MHRA), Great Britain

Food and Drug Administration (FDA), USA