1. The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
2. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of (EU) 2017/745 is issued.
Masqué
ZHANG Chao
1. 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;
2. The post-market surveillance obligations are complied with in accordance with Article 10(10) of (EU) 2017/745;
3. The reporting obligations referred to in Articles 87 to 91 of (EU) 2017/745 are fulfilled.