1) The technical documentation and the EU declaration of conformity are drwan up and kept up-to-date
2) The post-market surveillance obligations are complied with in accordance with Article 10(10)
3) The reporting obligations referred to in Articles 87 to 91 are fulfilled
4) In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
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LEE Keonhoon
1) The conformity of the device is appropriately checked, in acccordance 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)
3) The reporting obligations referred to in Articles 87 to 91 are fulfilled
4) In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued