(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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HAMMES Valerio
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
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JOHANSKI Brian
(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.
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BODOH Matthew
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date