ClaroNav Inc.

• drawing up and keeping up to date of the technical documentation and the EU declaration of conformity of aforementioned devices • fulfillment of the post-market surveillance obligations in accordance with Article 10(10) • fulfillment of reporting obligations referred to in Articles 87 to 91 • in the case of investigational devices, issuance of the statement referred to in Section 4.1 of Chapter II of Annex XV

• Ensuring 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;