What action should a manufacturer take after a serious incident with their CE-marked device, if it is determined that a Field Safety Corrective Action (FSCA) is not necessary?

When a serious incident occurs with a CE-marked device and it has been determined that a Field Safety Corrective Action (FSCA) is not necessary, the manufacturer is typically not required to report the incident formally. This is due to the fact that the absence of a need for an FSCA indicates that the situation does not pose an unacceptable risk to patient safety or public health, which would necessitate reporting or corrective actions.

In the context of regulatory frameworks, if a manufacturer assesses the incident and finds that it does not warrant an FSCA, this effectively means that they can conclude that the incident is manageable without additional oversight or communication to regulatory bodies.

While earlier reporting channels to the Competent Authority (CA), Notified Body (NB), or the EU Commission would be required if an FSCA were deemed necessary, this specific scenario indicates that no further action is needed to maintain compliance. Thus, the correct action in this instance is to recognize that no reporting is required, allowing the manufacturer to focus on ensuring the continued safety and performance of their device without additional burdens when the situation does not warrant it.