the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
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OMICCIOLI Enrica
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.