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).
To receive access to the Medical Devices Information System you need an individual access authorisation, consisting of the user code and the password. The process of the application of a user code is explained in the following.
Click on the right on the link "apply for a user code". Fill the form click on "weiter" (continue). You can choose your own usercode and password. Enter your address data and click on "weiter" (continue). The data you entered appears for verification in a new window. When you have checked the correctness of your data, click on "weiter" (continue). A confirmation will be shown that you have completed the process successfully and you will be sent an e-mail containing further instructions.
Click the button "Medical Devices Information System" and the following access page. Enter your user code and password and click on "Anmelden" (login).
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 "Nutzereinstellungen" (user settings) 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.
When you (as a sponsor) access the system for the first time, you have to fill out the "Erstanzeige Adresse" (initial notification address). Your user code assigned by DIMDI will be linked with a special sponsor code (= notifier code). This automatic linking of user code and sponsor code ensures that your are only able to access and edit your own notifications.
Please note, that the entire Medical Devices Information System is in German language.
Login to the MD-information system with your user code and password. When logging in for the first time, you will be automatically forwarded to the "Adresserfassung" (address registration).
The automatically generated form number is shown at the top of form section 1. Grunddaten (basic data). Please make note of this form number for later enquiries. If you only want to submit applications for CI/PE, select the organisation type "Sponsor" under "Anzeigender KL/LP" (notifier CI/PE). The indication of the sponsor refers to all types of sponsors (manufacturer, representative, other). The type of sponsor only needs to be specified in the application form for a concrete clinical study. Then click on the "speichern und weiter" (save and continue) button.
In the form section 2. Behörde (authority), select the competent authority(ies) responsible for your investigation(s). The information symbol [i] shows you the jurisdiction of the competent authorities (BfArM and PEI). Then click on the "speichern und weiter" (save and continue) button.
For the form section 3. Anzeigender (notifier), the data from your user code application are carried over. Make sure that all mandatory fields are filled out properly. You can correct false entries here. Then click on "speichern und weiter" (save and continue).
The form section 4. Sicherheitsbeauftragter (safety officer) is deactivated, since the information on the safety officer is not required for address registration exclusively for clinical investigations/performance evaluations.
Verify all of the entered data in the form section 5. Kontrolle (control). By clicking on the "bearbeiten" (edit) button, every individual form section can still be corrected.
At the end of the control section, confirm that you have entered all information according to the best of your knowledge and belief and enter the date (preset), city and name. Then click on the "Anzeige weiterleiten" (submit notification) button.
You will receive a confirmation page and an e-mail confirmation that your address notification has been duly received by DIMDI.
The "Klinische Prüfungen" (clinical investigations) area of the Medical Devices Information System consists of three components: