- 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.
- the post-market surveillance obligations are complied with in accordance with Article 10 (10)
- the reporting obligations referred in MDR Article 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.
Masqué
FADERAGAO Ma. Cristina
- ensuring that Technical Documentation and the EU Declaration of Conformity are drawn up and kept up to date