In the European Economic Area (EEA), the incident should also be reported to the Competent Authority
that the Member State, in which the user and/or patient is established, has designated responsible for
the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April
2017 on medical devices.
In the United States of America, the Medical Device Reporting regulation contains mandatory
requirements for manufacturers, importers, and device user facilities to report certain device related
adverse events and product problems to the FDA.
Follow the applicable laws or regulations on reporting device-related incidents or adverse events in the
jurisdiction(s) in which the system is being used.
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