sec_7_6_6__para__3

The manufacturer’s notification is followed by an assessment carried out by the surveillance authority, if possible together with the manufacturer. After the assessment, the authority must immediately inform the Commission, and the other Member States, of the incidents for which relevant measures have been taken or are contemplated. The Commission may then take any steps to coordinate, facilitate and support measures taken by the national surveillance authorities when dealing with the same type of incidents, or, if necessary, take measures at Union level (for example envisaging the re-classification of the device). A European database containing, among other information, data obtained in accordance with the vigilance system is managed by the Commission and made accessible to the competent authorities. The vigilance system is different from the safeguard clause procedure, since it requires notification even if the manufacturer takes the necessary measures on a voluntary basis. Nevertheless, when applying the vigilance system the surveillance authority is also obliged to adopt a restrictive measure vis-à-vis non-compliant CE marked products, if the conditions for invoking the safeguard clause apply and, accordingly, notify this measure following the safeguard clause procedure. However, the vigilance system does not necessarily have to come into play before the safeguard clause procedure is applied.

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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.