Responsible for conformity of the devices is appropriately checked, in accordance with the QMS system under which the devices are manufactured, before a device is released Technical documentation and the EU declaration of conformity are drawn up and kept up to date PMS obligations are complied with in accordance with Article 10 (10) Reporting obligations referred to in Articles 87 to 91 are fulfilled. Investigational devices, as per Section 4.1 of Chapter II of Annex XV.