Notification of Medical Devices and In vitro Diagnostics
Notifications on the first placing of medical devices on the market and on the safety officers, pursuant to § 96 MPDG and §§ 25 and 30 MPG, are to be reported using the online registration system.
The German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations- und Datenbanksystem, DMIDS) enables the reporting person to enter the data directly. Check routines support the accurate data input and therewith guarantee for a high degree of data quality. After the data are being forwarded, the competent authority is automatically informed by e-mail, the notification is processed and transferred to the database. An automatic e-mail is sent to the reporting person confirming that the competent authority has released the data into the database.
Please note that the entire information system is in German language!
Access to the information system
The person reporting has to request access authorisation (user code) for the information system. You will find a detailed guidance on the following site:
When the person reporting accesses the system for the first time and has filled out the initial notification address (Erstanzeige Adresse), the assigned user code will be linked with a special "Anzeigender-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.
Data entry by the person obligated to notify
The entire 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 § 96 MPDG and § 25 MPG). Each area consists of three components.
- Neue Anzeige (new notification)
After selecting the option "Neue Anzeige" (new notification), the type of notification is set and then the data can be entered. The entered data will be verified within the system for completeness and formal correctness. A notification can only be saved or forwarded once the person obligated to notify has carried out all the corrections suggested by the system. The competent authority can only view and process the data once they have been forwarded by the reporting person. The reporting person has exclusive write access in all the fields they have to fill out. - In Bearbeitung (in progress)
The "In Bearbeitung" (in progress) option provides the reporting person with the possibility to research, edit or even delete their own stored but not yet forwarded notifications. Furthermore, stored or registered initial notifications for products can be used as a template. By verifying the access rights, it is ensured that the competent authority cannot access notifications that are still being processed by the reporting person. The competent authority can only view the data after they have been forwarded to them. - Datenbestand (database)
The "Datenbestand" (database) option allows the person reporting to research their notifications that are registered by the competent authority and provides support with the preparation of notifications of change or withdrawal. The data from a researched notification are then adopted in the new form for the preparation of a notification of change. This ensures the automatic allocation of the initial and notification of change.
Another option can be selected at any time using the navigation bar. After the reporting person has entered and forwarded the data, the system automatically informs the competent authority of the corresponding notification via e-mail.
Further Handling by the Competent Authority
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 user group named in § 86 MPDG and § 33 MPG after the daily database update has been carried out. An automatic e-mail is sent to the person obligated to notify confirming that the competent authority has released the data. The competent authority only has write access to its own specified data fields.
Nomenclatures for Medical Devices
A standard nomenclature for medical devices is required to support the regulatory exchange of information within the framework of the MPDG and 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 German Medical Devices Information and Database System by means of a search function, but can also be downloaded free of charge as individual files.