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.
The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
The post-market surveillance obligations are complied with in accordance with Article 10(10). The reporting obligations referred to in Articles 87 to 91 are fulfilled.
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LEISCHNER Franziska
In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued