BGI PathoGenesis Pharmaceutical Technology Co., Ltd.

a) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. b) in the case of investigational devices or devices for performance studies, the statement referred to Regulation (EU) 2017/746 Section 4.1 of Annex XIV is issued.

a) 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. b) the post-market surveillance obligations are complied according to Regulation (EU)2017/746. c) the reporting obligations referred to in Regulation (EU) 2017/746 are fulfilled.