With its barrier-free (according to BITV, German Barrier-free Information Technology Ordinance), graphical user interface the German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations-und Datenbanksystem, DMIDS) contributes to the market surveillance of medical devices in Germany. Based on the German Medical Devices Act (MPG) as well as the Medical Device Law Implementing Act (MPDG), persons reporting and sponsors register and edit the required forms via the intuitively operated interface and refer them to their respective competent authority.

The system requirements are listed on the following website:

Access

To receive access to the Medical Devices Information System you need an individual access authorisation, consisting of the username (user code) and the password. The process of the application of a user code is explained in the following.

The registration form as well as the entry to the information system can be found on this website:

Portals - DMIDS

Click the button "apply for access". Fill the form and click on "next". You can choose your own usercode and password. Enter your address data and click on "next". The data you entered appears in a new window for verification. When you have checked the correctness of your data, click on "next". A confirmation will be shown that you have completed the process successfully and you will be sent an e-mail containing further instructions.

Structure and Operating Controls

The navigation bar at the top of the screen enables easy access to the desired areas and through the opening of submenus, it shows the area you are currently in. Possible actions are triggered by clicking on the labelled coloured buttons, e.g. "speichern und weiter" (save and continue), "bearbeiten" (edit) and "Datei hochladen" (upload file).

The entry of information in the data fields takes place in form sections arranged like a register. The mandatory fields, i.e. fields that must be filled out, are indicated with an orange-coloured point (•). In every form section, a plausibility check and storing of the entered data takes place by clicking the "speichern und weiter" (save and continue) button. By clicking the button "Formulareingabe abbrechen" (cancel form entry), the data entered in the current form section are deleted. The entered data remains in those form sections that have previously been stored.

When the mouse pointer touches an information symbol [i] beside the data field name, an additional help text is shown for the corresponding data field.

After clicking the "speichern und weiter" (save and continue) button, formally false or missing entries in the form sections are indicated through highlighting of the respective data field and a specific error prompt text. All of the entered data are shown in the last section of each form, "Kontrolle" (Check). By clicking the "bearbeiten" (edit) button, each respective form section can still be corrected.

In the "Nutzereinstellungen" (user settings) navigation point, you can individually configure different system parameters, e.g. changing the password, automatic masking of search terms, number of search results displayed.

Sponsors

Please note that the entire Medical Devices Information and Database System is in German language.

Login to the information system with your usercode and password.

The "Klinische Prüfungen" (clinical investigations) area of the Medical Devices Information and Database System consists of three components:

• Erfassung (Entry)
  The option "Erfassung" (Entry) allows the sponsor to enter the data for initial applications for approval or notifications of change. The entered data will be verified within the system for completeness and formal correctness if necessary. An application can be saved at any time but forwarding is only possible once all the corrections suggested by the system have been carried out. The competent authority (BfArM, BfS or PEI) and the Ethics Committee can only view and process the data once it has been forwarded by the sponsor. The sponsor has exclusive write access in all the fields he has to fill out. After the sponsor has entered and forwarded the data, the system automatically informs the competent authority and Ethics Committee of the corresponding application per e-mail.
• In Bearbeitung (in progress)
  The "In Bearbeitung" (in progress) option provides the sponsor with the possibility to research, view, edit or delete if necessary their own stored applications/notifications before they have been finally registered by the authorities. After having filled in the form completely, it can be saved only or forwarded to the competent authority (BfArM, BfS or PEI). The status of a form can be seen in the overview table. By verifying the access rights, it is ensured that the competent authority and the Ethics Committee cannot access applications/notifications that are still being processed by the sponsor and vice versa. The competent authority and the Ethics Committee can only view the data after it has been forwarded to them. Any saved form can be used as a template.
• Datenbestand (database)
  The "Datenbestand" (database) option allows the sponsor to research their applications that are finally registered and provides support with the preparation of e.g. applications of change. The "Datenbestand" view of an application also includes functions to initiate a new form in order to modify the application (amendment, notification of termination etc). Using these functions, the data that were last authorised are copied into the new form.