a) conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released;
b) technical documentation and the EU DoC are drawn up and kept up-to-date;
c) PMS obligations are complied with in accordance with Article 10(10);
d) reporting obligations referred to in Articles 87-91 are fulfilled;
e) in case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.