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Medical Devices

Assessing risks. Protecting patients.

Medical Devices

Medical devices are products that have a medical purpose and are intended by the manufacturer for use in humans. In contrast to medicinal products that act pharmacologically, immunologically, or metabolically, the main intended purpose of medical devices is primarily achieved by physical means.
Medical devices include implants, products for injection, infusion, transfusion and dialysis, medical instruments intended for use in humans, software, catheters, artificial cardiac pacemakers, dental devices, bandaging material, corrective lenses, x-ray machines, condoms, instruments for use by physicians, laboratory diagnostics, contraceptive devices as well as in vitro diagnostic agents. Products that contain or are coated with a substance or preparations of substances which are considered to be medicinal products or components of a medicinal product (including plasma derivatives) if used separately and which are liable to act upon the body with action that is ancillary to that of the device are also considered to be medical devices. The legal definition of medical devices is given in Section 3 of the Act on Medical Devices (MPG).

The BfArM's tasks with regard to medical devices are also laid down in the Act on Medical Devices ("Medizinproduktegesetz"), the Ordinance on the Medical Device Safety Plan ("Medizinproduktesicherheitsplanverordnung", MPSV), and the Ordinance on Clinical Investigations with Medical Devices ("Verordnung über klinische Prüfung von Medizinprodukten", MPKPV).

These tasks focus especially on the evaluation of so-called incident reports. These are risks reported in connection with products already on the market which the BfArM receives from operators (physicians, hospitals). Such incident reports can then lead to the initiation of a risk assessment procedure by the BfArM. If the BfArM comes to the conclusion that the product has to be changed for safety reasons, it will issue a recommendation for the manufacturer and/or the competent supervisory authority of the "Land". The legal instruments for implementing these recommendations lie with those authorities.

Furthermore, the BfArM is responsible for the authorisation of clinical investigations of medical devices. A clinical investigation is conducted in trial subjects in order to assess the safety and/or the performance of a medical device. Such investigations are necessary if clinical data from literature, clinical experience, or previously performed clinical investigations is not sufficient.

Upon request by the competent authority of the "Land", a notified body, or the manufacturer, the BfArM also decides on the classification of individual medical devices and their demarcation from other products.