DMIDS
German Medical Devices Information and Database System
Tasks
Extensive information is required for the market surveillance of medical devices. The continuous exchange of information between the competent institutions is a prerequisite for safe medical devices in Germany and Europe.
The DMIDS provides the digital framework so that these data exchanges between the authorities and other user groups can proceed in a structured matter. The information system enables online-based data entry and editing by persons reporting and sponsors, notified bodies and competent authorities.
Further contents of DMIDS
Notification of Incidents and SAE with Medical Devices
Incidents and serious adverse events (SAE) in clinical trials with medical devices must be notified to BfArM and/or PEI. The incident and SAE reports are stored in DMIDS and are available for research to the appropriate institutions.
More information as well as the report forms can be found on this website:
Classification of medical devices and determination of the legal status
Medical devices are classified according to their intended purpose. When there are differences of opinion between the manufacturer and the notified body on the classification of a medical device or in vitro diagnostic medical device or on the legal status of a device, the BfArM decides in accordance with § 85 (2) 1 MPDG.
The BfArM enters the notifications on the classification of medical devices or on the legal status of devices in the German Medical Devices Information and Database System. Only the competent authorities currently have access to this database.
More information as well as the application forms on can be found on this website:
Certificates for Medical Devices
The notified bodies certify the manufacturers that a medical device or quality management system conforms to the respective regulatory requirements. Since January 1st 2004, the German notified bodies enter the notifications on issued, restricted, suspended, withdrawn or refused certificates (according to § 18 Medical Devices Act, MPG) in the Medical Devices Information System. Temporarily, the same applies for MDR and IVDR certificates on basis of § 96 (2) Medical Device Law Implementing Act (MPDG).
Currently, the notified bodies and competent authorities have access to this database.
The addresses, identification numbers and scope of the notified bodies in Germany and the EEA member countries as well as the notifying authorities can be found under:
