Vigilance System
According to the Act on Medical Devices (MPG) and the Ordinance on Medical Devices Vigilance (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 any incident is suspected to have been caused by an electromagnetic interaction with any device other than a medical device, then the Federal Office for Posts and Telecommunications shall be involved.
The Act on Medical Devices (MPG) and the Ordinance on Medical Devices Vigilance (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 to notify 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 an authorised representative has not 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 to notify incidents or recalls?", bullet 2 and 3, shall be made immediately.
Notification forms
Please click on forms to open the notification forms (PDF or DOC).
Statistical Data
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
Kurt-Georg-Kiesinger-Allee 3
D 53175 Bonn
Facsimile: +49 228 99-307-5300
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)
Off-time availability in urgent cases:
Telephone: +49 173 9132686
The Paul-Ehrlich-Institute is responsibly 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 und II, hepatitis B, C und 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 und B.
Incidents regarding the above mentioned products shall be addressed to:
Paul-Ehrlich-Institut
Referat Sicherheit In-vitro-Diagnostika
Paul-Ehrlich-Straße 51-59
D 63225 Langen
Facsimile: +49 6103 77-1268
E-Mail: s-ivd@pei.de
Telephone: +49 6103 77-7000 or -3114
Off-time availability in urgent cases:
Telephone: +49 173 3202 -800
Facsimile: +49 173 3202 -751