enicor GmbH

The technical documentation and the EU declaration of conformity in respect of the Devices are drawn up and kept up-to date; In the case of investigational devices (if any), the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued; and In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies, the statement referred to on section 4.1 of Chapter I of Annex XIV of the IVDR is issued.

The conformity of the Devices is appropriately checked, in accordance with the quality management system under which the Devices are manufactured, before each Device is released; The post-market surveillance obligations related to the Devices are complied with in accordance with the Regulations; and The vigilance reporting obligations (as referred to in Articles 87 to 91 of the MDR and Articles 82 to 86 of the IVDR) are fulfilled in respect of the Devices