In according with the Act on Medical Devices (MPG) and the German Safety Plan for Medical Devices (MPSV), the Federal Institute for Drugs and Medical Devices (BfArM) ensures the central collection, analysis and evaluation of risks arising from the use or application of medical devices, in particular, adverse effects, interactions with other substances or products, contra-indications, falsifications, operational defects, malfunctions and technical defects and in so far co-ordinates the necessary measures to be taken.
In fulfilling these tasks, the Federal Institute for Drugs and Medical Devices collaborates with the authorities of the other states party to the Agreement on the European Economic Area and the Commission of the European Communities, the World Health Organization, the authorities of other countries responsible for public health as well as occupational safety and health, the authorities of the Laender responsible for public health, occupational safety and health, radiation protection, and metrology and other higher federal authorities which are concerned from a technical viewpoint, notified bodies in Germany, the competent occupational accident insurance funds, the medical advisory service of social health insurance, the pertinent professional societies, the manufacturers and distributors, as well as other bodies which compile data on risks associated with medical devices in the fulfilment of their tasks. If an incident is suspected to have been caused by an electromagnetic interaction with any device other than a medical device, the Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railway (Bundesnetzagentur) shall be involved.
The MPG and the MPSV is available on the Legislation website.
What types of incidents or recalls have to be notified?
- Incidents that have occurred in Germany. An incident is any malfunction, any failure or deterioration in the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use which has led, or could have led, directly or indirectly, to the death or serious deterioration in the state of health of a patient or user or another person.
- Recalls of medical devices implemented in Germany. A recall is a corrective measure leading to return, exchange, conversion or improvement, isolation or destruction of medical devices.
- Incidents occurred outside the European Economic Area if they have led to corrective measures that are also relevant to medical devices which are marketed within the European Economic Area. In such cases the Federal Institute shall be notified if the person responsible for the first placing on the market of the device is based in Germany or if the notified body is based in Germany in case of active implantable medical devices, in vitro diagnostic medical devices in accordance with Annex II of Directive 98/79/EC, in vitro diagnostic medical devices for personal use according Directive 98/79/EC or other class IIa, IIb or III medical devices.
Who is responsible for notifying incidents or recalls?
- The person responsible for the first placing on the market of the device (manufacturer or his or her authorised representative). If the manufacturer does not have his/her registered place of business in the European Economic Area and if authorised representative has been designated, or if medical devices are not being imported into the European Economic Area under the responsibility of the authorised representative, the importer is the person responsible.
- Operators or users of medical devices if the device is operated or used within a professional or commercial framework.
- Distributors, traders and persons authorised to practice medicine or dentistry who sell medical devices to patients or other laypersons for personal use.
What are the time limits for reporting?
- Incidents should be reported without delay in accordance with the required urgency of attention but in any case within a maximum of 30 days of these becoming known.
- If a delay is likely to cause danger, the notification shall be made immediately.
- Recalls and incidents that occurred outside the European Economic Area (see bullet 3, "What types of incidents or recalls have to be notified?") shall be reported at the latest by the time of implementation of any measures.
- Notifications and reports referred to in section "Who is responsible for notifying incidents or recalls?", bullets 2 and 3, shall be made immediately.
Please click on forms to open the notification forms (PDF).
Statistical Data (in German language)
To which Competent Authority should incidents or recalls be reported?
Federal Institute for Drugs and Medical Devices
- Medical Devices Division -
D 53175 Bonn
Non-active medical devices
Dr. Josef Zündorf
In vitro diagnostics and active medical devices
Dr. Ekkehard Stößlein
Off-time availability in urgent cases
The Paul-Ehrlich-Institute (PEI) is responsible for the following reagents and reagent products including materials for calibration and control according to Annex II of Directive 98/79/EC:
HIV 1 and 2, HTLV I and II, hepatitis B, C and D, rubella, toxoplasmosis, cytomegaly virus, chlamydia, AB0 system, rhesus (C, c, D, E, e), Kell system, Duffy system, Kidd system, irregular anti-erythrocyte-anti body, HLA tissue types DR, A and B.
Incidents regarding the above mentioned products shall be addressed to:
- Referat Pharmakovigilanz II -
D 63225 Langen
Telephone: +49-(0)6103-77-3115 or -3114