1. 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; 2. The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 3. Compliance with post-market surveillance obligations and incident reporting obligations 4. In the case of investigational devices, ensure the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.