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