AViTA Corporation

1. The reporting obligations referred to in Articles 87 to 91 are fulfilled of Regulation (EU) 2017/745. 2. In the case of the investigational devices, the statement to ensure that the medical equipment used in clinical investigational conforms to the general safety and performance requirements and that every precaution has been taken to protect the health and safety of the subjects when involved.

1.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. 2. The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. 3.The post-market surveillance obligations are complied with in accordance with Article 10(10) of Regulation (EU) 2017/745.