ImmunoDiagnostic Systems France

Principal responsible for ensuing that : - the conformity of the devices is appropriately checked, in accordance with the quality management system, before a device is released - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date - the post-market surveillance obligations are complied - the reporting obligations are fulfilled - in the case of investigational devices, the statement referred to in the IVDR is issued.

Alternate person responsible for ensuing that : - the conformity of the devices is appropriately checked, in accordance with the quality management system, before a device is released - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date - the post-market surveillance obligations are complied - the reporting obligations are fulfilled - in the case of investigational devices, the statement referred to in the IVDR is issued.

Alternate responsible for ensuing that : (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the reporting obligations referred to in Articles 87 to 91 [Article 82 and 86 of the IVDR] are fulfilled;