The conformity of the device is checked, in accordance with the quality management system under which the devices are manufactured, before releasement;
The technical documentation and the EU DoC are managed and updated;
The post-market surveillance obligations are in accordance with Article 10(10);
Reporting obligations referred to in Articles 87 to 91 are fulfilled;
In the case of investigational devices, the statement referred to in Section 4.1 of chapter II of Annex XV is issued.