7.6.6 医療機器：ビジランスシステム

Risks posed by medical devices have necessitated a comprehensive monitoring system whereby all serious product incidents will be reported (315). The medical devices vigilance system applies to all incidents (316) which directly or indirectly might have led to, the death or a temporary or permanent serious deterioration of a patient’s, user, or other person’s state of health or a serious public health threat, and which resulted from:

—any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features;

—any inadequacy in the labelling or the instructions for use; or

—any technical or medical reason in relation to the characteristics or performance of a device, and which leads the manufacturer to systematically recall all devices of the same type.

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.

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.