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Guidance Sponsor: Adress Notification

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).

Screenshot: Guidance Sponsor - Adress Notification

 

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.

Screenshot: Wegweiser Anzeigepflichtige - Adresse Erstanzeige Grunddaten

 

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.

Screenshot: Guidance Sponsor - Adress Notification Authority

 

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).

Screenshot: Guidance Sponsor - Adress Notification Sponsor

 

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.

Screenshot: Guidance Sponsor - Adress Notification Control

 

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.

Screenshot: Guidance Sponsor - Adress Notification submit

 

You will receive a confirmation page and an e-mail confirmation that your address notification has been duly received by DIMDI.