(a): the conformity of the devices is appropriately checked before a device is released;
(b): the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c): the post-market surveillance obligations are complied with in accordance with Article 10(9);
(d): the reporting obligations referred to in Articles 82 to 86 are fulfilled;
(e): the statement referred to in Section 4.1 of Annex XIV is issued for performance studies involving risks for subjects.