Clinical investigations and performance studies
Pursuant to the Regulations (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR, application dates May 26, 2021 and May 26, 2022) as well as German national regulations a favourable opinion of the competent ethics committee and an approval of or notification to the competent authority is required in order to perform a clinical investigation / performance study for medical devices.
The sponsor must submit the respective applications via the German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations- und Datenbanksystem, DMIDS, formerly named Medizinprodukte-Informationssystem / Medical Devices Information System).
The DMIDS supports the sponsor to enter the data with check lists and useful hints. Check routines support the correct entry of the data and thus guarantee a high degree of data quality. When the sponsor has forwarded, i.e. submitted the data, the ethics committee and/ or the competent authority (BfArM or PEI) will automatically be informed via e-mail, depending on the chosen workflow. They will assess the applications and release them into the database. The competent federal state authorities responsible for the sponsor and the study sites, i.e. the local authorities, will then be automatically informed via e-mail about the applications. There is also an automated e-mail response to the sponsor regarding the release of the data by the competent authority (BfArM or PEI) and the ethics committee.
The workflow for MDR/IVDR applications is depicted here:
On May 5, 2021 BfArM alongside other institutions held an online event on the topic of performing clinical investigations under the new requirements of the MDR. On May 11, 2022 an online event on the new requirements for IVDs and Companian Diagnostics (CDx) was held.
The presentation slides can be found here (in German language):
BfArM im Dialog: Klinische Prüfungen von Medizinprodukten - Was ändert sich mit MDR und MPDG?
Please note that the entire DMIDS is in German language. For a translation of the required terms you may use the German/English PDF version of the application form which is available in the list of open applications ("In Bearbeitung") as soon as you have created and saved the form once.
For further information on legal aspects please see:
Access to the information system
The sponsor or his representative for the procedure has to request access authorisation (user code) for the information system. You will find a detailed guidance at Operating the system.
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).
Data entry by the sponsor
The module "Klinische Prüfungen" (clinical investigations) of the DMIDS 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 be saved at any time for later editing but it can only be forwarded, i.e. submitted 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 search and edit their own applications/notifications and, if necessary, to delete stored but not yet forwarded applications/notifications as well as use them as a copying template. The sponsor can forward the unchanged MDR/MPDG and IVDR/MPDG applications from the "In Bearbeitung" component to the competent authority within the sequential procedure after the ethics committee has registered the positive decision.
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 search their applications that are final processed by the competent authority (BfArM or PEI) and the ethics committee and offers support in the creation of e.g. amendments. The data of a researched application is used for the creation of an amendment.
Another option can be selected at any time via the navigation bar. After the sponsor has entered and forwarded the data, the responsible ethics committee and competent authority are automatically informed of the application by the system via e-mail. The sponsor also receives an automated response about the submission of his application, which, however, does not replace the confirmation of receipt by the responsible competent authority and ethics committee, which is decisive for the processing deadlines. In the case of multicentre clinical investigations or performance evaluations conducted in more than one study site within the scope of the MPG, the DMIDS notifies each registered, involved ethics committee responsible for assessing the qualification of the investigators and the suitability of the study sites.
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 that are intended for them. They only have write access in these data fields. As long as the competent authority or ethics committee has the write access the sponsor cannot edit the form. In order to resolve open issues, the competent institution can issue a "Nachforderung" (= request for additional information). For this, the form can be made completely editable or editing can be restricted to attachments only. After finalisation, the approved applications will be released into the database. Following the daily updating of the database, the data are available online for the user groups with access rights normally on the next working day. The local competent authorities are sent an automated e-mail regarding the new entries accordingt to their competencies. This e-mail does not contain the decision itself. Any detailed information can only be retrieved from the system.
Address and contact information of the competent ethics committees:
Further information including screenshots from the system is available in the guidance for sponsors. Please note the English version only contains the basic information and will be updated to the new regulations later. For MDR applications a new German guidance has been published recently here: