(a) the conformity of the devices is appropriately checked, in accordance with the quality management system (QMS) under which the devices are manufactured before a device is released
(b) the technical documentation and the EU declaration of conformity.
(c) the post-market surveillance obligations are complied.
(d) the reporting obligations are fulfilled; in the case of investigational devices, in the case of investigational devices, the statement that must be referred is issued.