Delcath Systems Inc.

Responsible for supervision and control of the manufacture of devices, and post-market surveillance and vigilance activities concerning them. Responsibilities mentioned in Article 15 of 2017/745: Ensure the conformity of devices is appropriately checked, in accordance with the quality management system before devices are released. Ensure Technical Documentation and EU Declaration of conformity are drawn up and kept up to date. Post-Market Surveillance (PMS) Vigilance Reporting obligations