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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 application form for clinical investigation from Annex 4 of the DIMDI-Verordnung for a translation of the required terms (see page 3):

Verordnung über das datenbankgestützte Informationssystem über Medizinprodukte des Deutschen Instituts für Medizinische Dokumentation und Information (vom 4. Dezember 2002, zuletzt geändert 10. Mai 2010)

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).

Screenshot: Guidance Sponsors - Overview


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

Screenshot: Guidance Sponsors - Overview KP/LP


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

Screenshot: Guidance Sponsors - KP/LP Application type


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 institution by choosing "Kopiervorlage" (master copy) and then "vorhandenen Antrag als Kopiervorlage verwenden" (use available application as master copy). To enter the initial application, select the option "neuer Antrag" (new application) under "Kopiervorlage" (master copy). Then click on "weiter" (next).

Screenshot: Guidance Sponsors - KP/LP notification type


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).

Screenshot: Guidance Sponsors - KP/LP Competent authority


The "Formularnummer" (form number) and "Antragsnummer" (application number) are automatically generated and are shown at the top of form section  1. Allgemein (general). Please note these numbers for later enquiries.

Enter all of the required data regarding the "Sponsor" (sponsor), "Vertreter des Sponsors mit Sitz in EU" (representative of the sponsor in EU) and "Verfahrensbevollmächtigter" (authorized representative for the procedure).

Please note: The e-mail address entered in the sponsor´s address fields will be used to automatically inform the person responsible for the application procedure about the status of the application. Please make sure to enter the correct e-mail address there!

Click on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP general


In the form section 2. Produzent (manufacturer), enter all of the required data regarding the manufacturer (in case the sponsor is not the manufacturer) and external sterilization site (if any). If the manufacturer is identical with the sponsor, you only choose the check box "Produzent ist identisch mit dem Sponsor". Click on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP manufactorer


In the form section 3. 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).

Screenshot: Guidance Sponsors - KP/LP investigator


In the form section 4. 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 the responsible ethics committee, click on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP ethics committee


In the form section 5. Medizinprodukt (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).

Screenshot: Guidance Sponsors - KP/LP medical device


In the form section 6. Vergleichsprodukt (product used as comparator) enter a product used as comparator, if applicable. Click on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP product used as comparator


In form section 7. Zuständige Behörde für den Sponsor (competent authority for sponsor) choose your competent authority. Click on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP competent authority for sponsor


In form section 8. Prüfung (clinical investigation) enter all information on the clinical investigation/performance evaluation. Then click on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP clinical investigation


The information on the study sites must be entered in the subforms of form section 9. Prüfstellen (study sites). Here, you have to 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. In the application directed to the ethics committee, the following data are required additionally: 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 has to be confirmed by clicking on "speichern und weiter" (save and continue).

Screenshot: Guidance Sponsors - KP/LP study sites


In the form section 10. 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). Choose the file, you want to upload. Then click on "Datei hochladen" (upload file).

If you would like to summarize several required appendices, you have to click on the check box "Anlage nicht erforderlich" (appendix not required) for all types of appendix left out and give a useful comment to refer to the file which contains the respective information.

Please, do not upload the same file several times under different types of appendix. You can find a list of required appendices in the "Verordnung über klinische Prüfungen von Medizinprodukten"(MPKPV)

Screenshot: Guidance Sponsors - KP/LP appendices


Verify all of the entered data in the form section 11. Kontrolle (control). By clicking on the button "bearbeiten" (edit), each 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).

Screenshot: Guidance Sponsors - KP/LP control


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.