Notifications on the first placing medical devices on the market and on the safety officers, pursuant to §§ 25 and 30 section 2 MPG, are to be reported using the internet-based registration system.
The Medical Devices Information System, developed by DIMDI, enables the reporting person to enter the data directly. Checking routines support the accurate notification input and therewith guarantee for a high degree of data quality. After the data is forwarded by the person reporting, the competent authority is automatically informed by e-mail, the notification processed and released to the database. An automatic e-mail is sent to the person obligated to notify confirming that the data has been released to the database by the competent authority.
Please note, that the entire Medical Devices Information System is in German language.
The person reporting has to request access authorisation (user code) for the Medical Devices Information System through the DIMDI website. Click on the right on the link "apply for a user code". You will find a detailed guidance on the following site: User code application.
When the person reporting accesses the system for the first time and has filled out the initial notification address (Erstanzeige Adresse), the user code assigned by DIMDI will be linked with a special "Anzeigenden-Code" (notifier code). This automatic linking of user code and notifier code ensures that the person reporting is only able to access and edit their own notifications.
The entire Medical Devices Information System is divided into different individual areas. There are separate areas specific to the notification of medical devices and in vitro diagnostics (according to § 25 Medical Devices Act, MPG). Each area consists of three components.
Another option can be selected at any time through the navigation bar. After the reporting person has entered and forwarded the data, the system automatically informs the competent authority of the corresponding notification per e-mail.
After examining the notifications the authority's predetermined mandatory fields (e.g. registration no. and date of registration) are to be completed. The data sets are released individually and are available online for the circle of users named in § 5 DIMDIV after the daily database update has been carried out. An automatic e-mail is sent to the person obligated to notify confirming that the data has been released by the competent authority. The competent authority only has write access to its own specified data fields.
A standard nomenclature for medical devices is required to support the regulatory exchange of information within the framework of the Medical Device Act (MPG). Currently, the German version of the Universal Medical Device Nomenclature System (UMDNS) is to be used for medical devices, and for in vitro diagnostics, the English classification from the European Diagnostic Manufacturers Association (EDMA). These nomenclatures are integrated into the Medical Devices Information System by means of a search function, but can also be downloaded free of charge as individual files.