Incident report
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 to be used as of 1.1.2020
The European authorities, together with the manufacturers' associations, have agreed on a new report form to be used as of 01.01.2020 by the manufacturers and their authorised representatives.
The help text for this form can be found here:
If PDF documents cannot be viewed with Firefox, please save locally or click here.
The XSDs for direct reporting from manufacturer databases can be downloaded here:
The Medical Device Coordination Group (MDCG) has compiled further information on the reporting of serious incidents: