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
The reporting obligations
The issuing of the statement referred to in Section 4.1 of Chapter II of Annex XV (REGULATION (EU) 2017/745) for investigational devices