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