*Ensure that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
*Comply with the reporting obligations referred to in MDR Articles 87 to 91 are fulfilled
*For investigational devices: Provide the statement referred to in MDR Section 4.1 of Chapter II of Annex XV is issued
*Ensure that the post-market surveillance obligations are complied with in accordance with Article 10 (10)
Masqué
ROSENSTEIN Rachel
*Ensure 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