The conformity of the devices is appropriately checked, in accordance, with the quality management system under which the devices are manufactured, before the device is released.
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GFOELLER Elizabeth
The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; and
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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SIMONOTTI Laura
The post-marketing surveillance obligations are compiled in accordance with Article 10(10); and
the reporting obligations referred to in Articles 87 and 91 are fulfilled