BioGX Inc.

•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 referred to in Articles 82 to 86 are fulfilled; •the statement referred to in Section 4.1 of Annex XIV devices for performance studies is issued.