General Information Medical Devices Information System

On March 21st, 2010 the whole Medical Devices Information System was converted to a new, intuitively operated, barrier-free graphical user interface. With the coming into force of the German law on the amendment of medical device regulations on March 21st 2010, the legal amendments for the field of clinical investigations, among other things, were implemented in the MD Information System. Furthermore, graphical software interfaces must be designed to be barrier-free according to BITV (German Accessible Information Technology Ordinance).

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

The following information gives you an overview of the system's structure and operating controls.

Structure and operating controls

The navigation bar at the left edge 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 on the "speichern und weiter" (save and continue) button. By clicking on 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 on the "speichern und weiter" (save and continue) button, formally false or missing entries in the form sections are indicated through yellow highlighting of the respective data field and a specific error prompt text. The next form section follows only once all data have been entered correctly. All of the entered data are shown in the last section of each form, "Kontrolle" (Control). By clicking on the "bearbeiten" (edit) button, each respective form section can still be corrected.

In the "Voreinstellungen" (presetting) navigation point, you can individually configure different system parameters, e.g. changing the password, time specification for automatic logout when inactive, highlighting of search terms, number of search results displayed.

Sponsors

The "Klinische Prüfungen" (clinical investigations) area of the Medical Devices Information 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 only be saved or forwarded by the sponsor once all the corrections suggested by the system have been carried out. The competent authority (BfArM 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 (BfArM or PEI) 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, edit, delete if necessary their own stored but not yet forwarded applications/notifications, or to use them as a template. By verifying the access rights, it is ensured that the competent authority (BfArM or PEI) and the Ethics Committee cannot access applications/notifications that are still being processed by the sponsor. The competent authority (BfArM or PEI) and the Ethics Committee can only view the data after it has been forwarded to them.
• Datenbestand (database)
  The "Datenbestand" (database) option allows the sponsor to research their applications that are authorised by the competent authority (BfArM or PEI) and the Ethics Committee and provides support with the preparation of e.g. applications of change. The data from a researched application are then adopted for the preparation of an application of change. This ensures the automatic allocation of the initial and modification application.