DNA Genotek Inc.

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.

Conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; In the case of investigational devices, the statement in Section 4.1 of Chapter II of Annex XV is issued; in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement in Section 4.1 of Annex XIV is issued