Ensuring that: the conformity of the devices is appropriately checked, in accordance with the quality management system before a device is released. Technical documentation and EU declaration of conformity are drawn up/kept up to date. The PMS obligations are complied with in accordance with Article 10. The reporting obligations referred to in Articles 87 to 91 are fulfilled. For investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.