Clinical Investigations and Performance Evaluations
The sponsor can use the Medical Devices Information System to submit the applications for approval of a clinical investigation/performance evaluation for medical devices to the competent authority, and for affirmative evaluation to the competent Ethics Committee.
The German Medical Devices Information System allows the sponsor to enter the data directly. Check routines support the correct entry of the data and thus guarantee a high degree of data quality. When the sponsor has forwarded the data, the competent authority (BfArM or PEI) and the Ethics Committee will be automatically informed per e-mail, and they will then process the applications and release them in the database. The competent federal state authorities responsible for the study sites will then be automatically informed per e-mail about the approved clinical investigation/performance evaluation. There is also an automatic e-mail response to the sponsor regarding the release of the data by the competent authority (BfArM or PEI) and the Ethics Committee.
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):
Access to the Medical Devices Information System
The sponsor has to request access authorisation (user code) for the Medical Devices Information System. Click on the right on the link "apply for a user code". You will find a detailed guidance on the following site: User code application.
When the sponsor accesses the system for the first time and has filled out the "Erstanzeige Adresse" (initial notification address), the user code assigned will be linked with a special sponsor code (= notifier code). This automatic linking of user code and sponsor code ensures that the sponsor is only able to access and edit their own notifications.
Data entry by the sponsor
The "Klinische Prüfungen" (clinical investigations) area of the Medical Devices Information System consists of three components:
- Erfassung (Entry)
After selecting the option "Erfassung" (Entry), the type of application and then the data can be entered. These will then 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.
- 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.
Another option can be selected at any time through the navigation bar. 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.
Further Handling by the competent authority (BfArM or PEI) and Ethics Committee
After verification of the application, the competent authority (BfArM or PEI) and Ethics Committee complete the data fields to their intent. They only have write access in these data fields. The approved applications will be released in the database. Following the daily updating of the database, the data is then available online in the user groups named in § 5 DIMDI-Verordnung. An automatic e-mail response is sent to the sponsor regarding the release of the data by the competent authority (BfArM or PEI) or Ethics Committee.
Address and contact information of the competent Ethics Committees according § 22 Medical Devices Act (MPG) are available under: