DIMDI provides for the market surveillance of medical devices by the competent authorities in Germany an up-to-date and central information system.
Manufacturer, sponsors and authorised representatives and as well the competent authorities use the information system at DIMDI for online data input and processing. Access codes (user codes) are also applied online. more »
The first placing of a medical device on the German market must be registered with the appropriate competent authority of the respective federal state. You can find the contact information of the authorities in Germany at DIMDI. more »
For a distinct data exchange the use of standard nomenclatures is necessary. DIMDI ist publisher of the German-language version of the Universal Medical Device Nomenclature System (UMDNS). At DIMDI you can find also the EDMA-Classification. more »
The Medical Devices Law (MPG) with its pertinent decrees and notices forms the legal basis for the information system and the general conditions for registration of medical devices, in-vitro-diagnostics etc. more »