Extensive information is required for the market surveillance of medical devices in Germany. DIMDI has set up an information system for medical devices according to § 33 Medical Devices Act (MPG), which enables internet-based data entry and editing by persons reporting, sponsors and the competent authorities.
As part of the redesign of the DIMDI website, the Guidance with user instructions have been transferred into manuals. The manuals for persons reporting and sponsors (in German) are still publicly available on our site.
The manuals for competent institutions are available within the Medical Devices Information System, where other documents such as the training materials are also uploaded. For this you need to be logged in with your username and password.
Please note, that the entire Medical Devices Information System is in German language.
The following information gives you an overview of the system's structure and operating controls.
The first placing on the market of MD and IVD as well as information regarding the safety officer must be notified with the Medical Devices Information System.
Starting from March 21, 2010, CI and PE must be approved by the competent authority (BfArM or PEI) and approvingly evaluated by an Ethics Committee before they may commence. The application forms for this purpose can be submitted online through the Medical Devices Information System.
Access for manufacturer, sponsors, authorised representatives and competent authorities. Please note, that the entire Medical Devices Information System is in German language.