sec_7_6_6__para__2

The manufacturer is responsible for activating the vigilance system and must, accordingly, inform the surveillance authority about incidents that invoke it. After the notification, the manufacturer is obliged to make investigations, send a report to the surveillance authority and consider, in collaboration with the authority, what action should be taken.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.