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Recital 76

Recital 76

(76)Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers of any suspected serious incidents and, where a manufacturer confirms that such an incident has occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.

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