If a manufacturer learns that an incident with their CE-marked device in a foreign hospital does not require a FSCA, whom should they inform?

In the context of medical devices and the responsibilities of manufacturers related to incidents, if a manufacturer discovers that an incident with their CE-marked device does not necessitate a Field Safety Corrective Action (FSCA), they are not required to report it to any regulatory bodies or authorities. This is because FSCA is typically linked to situations where the risk of serious injury or death is present, and if the incident falls outside of these criteria, the manufacturer can determine that no reporting obligations exist.

By choosing not to report, the manufacturer is acknowledging that they have assessed the incident, found it does not pose a significant risk, and thus, their obligations under regulatory frameworks are satisfied. This is aligned with the principle of proportionality in regulatory compliance, which aims to ensure that only significant incidents that could affect patient safety or device performance need to be reported and acted upon. Therefore, when there's a determination that an incident does not warrant further action, no formal notification to external parties, such as the Competent Authority (CA), Notified Body (NB), or EU Commission, is necessary.