Eyenuk, Inc.

Responsible for ensuring that: the post-market surveillance obligations are compliant with Article 83 of EU MDR; the reporting obligations in Articles 87 to 91 of EU MDR are fulfilled; for investigational devices, the statement in Section 4.1 of Chapter II of Annex XV of EU MDR is issued; before releasing devices, their conformity is checked to the quality management system under which they are manufactured; the technical documentation and the EU declaration of conformity are kept up-to-date.