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Notifications of Medical Devices and In vitro Diagnostics

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.

Access to the Medical Devices Information System

The person reporting has to request access authorisation (user code) for the Medical Devices Information System through the DIMDI website. For security reasons, the user code is sent through the post, and the corresponding initial access password is sent per e-mail.

Apply for a user code

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.

Data entry by the Person obligated to notify

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:

  • 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. These will then be verified within the system for completeness and formal correctness. A notification can only be saved or forwarded once the person obligated to notify have carried out all the corrections suggested by the system. The competent authority can only view and process the data once it has been forwarded by the reporting person. The person obligated to notify have 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 it has 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 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.

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 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.

Nomenclatures for Medical Devices

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.

Nomenclatures for Medical Devices

In vitro Diagnostics Notifications to other European Member States

When German manufacturers/representatives want to transmit their notifications to other European member states, according to Article 10 section 6 of the 98/79 EC directive, the following form is still available to them to download.

Form for the Registration of Manufacturers and Devices of in vitro diagnostic medical devices

Contact with DIMDI

Do you still have questions or suggestions? Please contact us:

Phone: +49 221 4724-522
E-mail: Medical Devices