- 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);
- 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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RUELLAN Carole
- 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 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;