Device conformity
(a) 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;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
Masqué
CATANESE Giuseppina
PMS and reporting
(a) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(b) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(c) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.