- ensuring that 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;
- ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- ensuring that the post-market surveillance obligations are complied with in accordance with Article 10;
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- ensuring that the reporting obligations referred to in Articles 87 to 91 are fulfilled