DIMDI - Guidance MPI - Sponsor: Application for Approval of CI/PE

Guidance Sponsor: Application for Approval of Clinical Investigation (CI) or Performance Evaluation (PE)

Please note, that the entire Medical Devices Information System is in German language. You may use the following printed application form for clinical investigation for a translation of the required terms (see page 3):

Erste Verordnung zur Änderung der DIMDIV, vom 10. Mai 2010 (PDF, 613 kB)

The procedure for the initial application for approval of a clinical investigation or a performance evaluation is explained in the following.

Login to the MD-information system with your user code and password. On the overview page, select the navigation point "Klinische Prüfungen" (clinical investigations) or click on the button "Einstieg klinische Prüfungen" (Access to clinical investigations).

Select the navigation point "Erfassung" (entry) or click on the "Erfassung" (entry) button.

Enter the type of application or notification and click on "weiter" (next).

Select the type of sponsor and to whom you would like to submit the application (competent authority or ethics committee). An application can either first be sent to the competent authority (BfArM or PEI) and then to the ethics committee, or vice versa. The sequence and the time interval between these two steps are not prescribed. After entering and forwarding the initial application, you can submit the application with the same contents again to the next responsible authority by using the "Kopiervorlage" (master copy) and then "vorhandenen Antrag als Kopiervorlage verwenden". To enter the initial application, select the option "neuer Antrag" (new application) under "Kopiervorlage" (master copy). Then click on "weiter" (next).

Determine the type of your medical device and select the competent authority (BfArM or PEI). The information symbol [i] shows you which competent authority is responsible for which devices (in German language). Click on "weiter" (next).

The automatically generated "Formularnummer" (form number) is shown at the top of form section  1. Allgemein (general). Please make note of this form number for later enquiries.

Enter all of the required data regarding the sponsor, manufacturer (in case the sponsor is not the manufacturer) and external sterilisation equipment (if any). Click on "speichern und weiter" (save and continue).

In the form section 2. Leiter (investigator), fill out all required fields with information on the principal coordinating investigator of the clinical investigation or the principal coordinator of performance evaluation in Germany. Click on "speichern und weiter" (save and continue).

In form section 3. EK (ethics committee), select your responsible ethics committee formed according to the German federal state law. A list of the ethics committees is shown according to the respective German federal state of the CI/PE investigator. You can see a list of all the ethics committees registered in Germany by clicking on the button "Alle Ethik-Kommissionen anzeigen" (show all ethics committees). After selecting responsible ethics committee, click on "speichern und weiter" (save and continue).

The information on the study sites must be entered in the subforms of form section 4. Prüfstellen (study sites). Here, you must enter the address of the study site, the name(s) of the investigator(s), the federal state authority responsible for monitoring of the CI/PE and the involved ethics committee responsible for the study site, as well as appendices for the respective study site (specifications on the suitability of the study site, on the qualification of investigators without medical/dental education, and curriculum vitae or suitable proof of qualification of the investigators). Every subform must be confirmed by clicking on "speichern und weiter" (save and continue).

In form section 5. Produkt (medical device), enter the information on the identification of the device as well as the CE labelling. The information symbols [i] contain additional help texts (in German language). Click on "speichern und weiter" (save and continue).

In form section 6. Prüfung (clinical investigation), enter all information on the clinical investigation/performance evaluation. Then click on "speichern und weiter" (save and continue).

In form section 7. Anlagen BoB (competent authority appendices), attach all of the appendices required by the competent authority, BfArM or PEI, as files (study plan etc.). To do so, click on the button "Anlage hinzufügen" (attach appendix). In the subform select the type of the attached appendix in the drop down menu and then select the corresponding file on your local computer by clicking on the "Durchsuchen" (browse) button. Then click on "Datei hochladen" (upload file). .

You can add further files by clicking on the "Anlage hinzufügen" (attach appendix) button again. After uploading all of the required files, click on "speichern und weiter" (save and continue).

Verify all of the entered data in the form section 8. 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. In the drop down menu, select the option "Anzeige weiterleiten" (forward notification).

You will receive a confirmation page and an e-mail confirmation that your application/notification has been received by DIMDI and will be forwarded to the competent authority resp. ethics committee. The competent authority resp. all entered ethics committees will be automatically informed of your application/notification per e-mail.