Until the European Database on Medical Devices is fully functional according to Art. 33 of the Regulation (EU) 2017/745 (MDR) the reporting form linked below is to be used for:

• reports of serious incidents with medical devices by manufacturers excluding in vitro diagnostic medical devices (Art. 87 MDR)
• reports of incidents with in vitro diagnostic devices by manufacturers (Art. 82 IVDR)

Please note our privacy policy (text in German language).

New report form for manufacturers and authorised representatives, mandatory use from 1.11.2025
The European authorities, together with the manufacturers' associations, have agreed on a new notification form to be used by manufacturers and their authorised representatives from 1.11.2025 at the latest. Until then, version 7.2.1 can still be used, but this will no longer be made available by the BfArM.

Download the current report form and fill it out offline
If PDF documents are not displayed in the browser, please save the file locally (right-click on the form and select "Save target/link as").

The help text, the change log and the XSDs for direct reporting from manufacturer databases for this form can also be found under the link above.

The form, help text and change log are currently only available in English.

The Medical Device Coordination Group (MDCG) has compiled further information on the reporting of serious incidents: