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Notification on Incidents and SAE with Medical Devices

An incident is a malfunction, failure or a modification of the features or performance or an inaccurate label or instruction manual for a medical device, which directly or indirectly caused, may have caused in the past, or may cause in the future, death or a serious aggravation of the state of health of a patient, a user or another person (MPSV § 2 (1)).

According to the directive of the Ordinance on Medical Devices Vigilance (Medizinprodukte-Sicherheitsplanverordnung, MPSV), those responsible for the first placing on the market of medical devices are obligated to report incidents that occur in Germany as well as product recalls taking place in Germany to the Federal Institute for Drugs and Medical Devices (BfArM) and/or to the Paul-Ehrlich-Institute (PEI) according to its jurisdiction.

Sponsors and investigators are required to report serious adverse events (SAE) in clinical trials or performance evaluations to the competent authority (BfArM or PEI), according to § 3 (5) of the Ordinance on Medical Devices Vigilance (MPSV).

The report forms available on the BfArM website and recommended in the "Bekanntmachung zur Sicherheitsplanverordnung (MPSV)" must be used to report incidents and serious adverse events (SAE) in clinical trials.