MEDIKA-HITEX

- The conformity of the devices is appropriately checked, 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 are complied with - The reporting obligations. - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the Medical Devices Regulation is issued.