Clinical investigations and performance studies
Pursuant to the Regulations (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR) 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).
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, BfS 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, BfS or PEI) and the ethics committee.
Access and guidance
The sponsor or his representative for the procedure must request access authorisation (user code) for the information system. You will find a detailed guidance at Operating the system.
The workflow for MDR/IVDR applications is depicted here:
For further information on legal aspects please see:
Further information including screenshots from the system is available in the guidance for sponsors. For MDR applications a new English guidance has been published recently. You can find the guidance and other documents at Portals - DMIDS and directly in the system with the "Servicelinks" at the bottom underneath the form.
Transitional agreements
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.