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