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, authorities, and is complementing 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 Federal Institute for Drugs and Medical Devices (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 were decided 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 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 the information from the manufacturer that he voluntarily recalls 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 elimiate risks. The 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, anlaysis 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
Facsimile: (0228) 207-5300
E-Mail: medizinprodukte@bfarm.de
Telephone: +49 228 99-307-5382 (Non-active medical devices - Dr. Heinz)
Telephone: +49 228 99-307-5360 (In vitro diagnostic - Prof. Dr. Siekmeier)
Telephone: +49 228 99-307-5384 (Active medical devices - Dr. Stößlein)
Information on Risks provided by other Competent Authorities
Schweizerisches Heilmittelinstitut (Swissmedic), Switzerland
Agence Francaise de Sécurité Sanitaire des Produits de Santé (Afssaps), France
Medicines and Healthcare Products Regulatory Agency (MHRA), Great Britain
Food and Drug Administration (FDA), USA