Medical device incident reports play an important role in safety.

Medical device incident reporting

Anyone who manufactures, sells, distributes, owns or uses medical devices and is aware of an incident, deviation, defect or malfunction that could cause or has caused harm to the health of a user, or their death, is obliged to report it to IMA.

Those conducting clinical investigations of medical devices must also report all serious adverse events (SAE) that occur during the investigation. More detailed guidance is available in Regulation (EU) 2017/745.

Healthcare professionals, users and patients are encouraged to report all suspected incidents.

Forms for professionals and users

The appropriate form must be used for each report: