Glaukos Corporation

Ensure that the technical documentation and the EU Declaration of Conformity are drawn up and kept up-to date. PRRC shall verify that the following has occurred: • Technical Documentation (including Clinical Evaluation Report) is current • Declaration of Conformity is up to date • Certificates (CE and ISO 13485) • Compliance with GSPR

Ensure that post-market surveillance (PMS) obligations are complied with in accordance with Article 10(10). PRCC shall verify that the following has occurred: • PMS meetings are held at appropriate intervals • Post-market surveillance plan and report is prepared Ensure that the reporting of obligations referred to in Articles 87 to 91 are fulfilled, specifically Vigilance reporting of serious incidents, Trend reporting, Analysis of serious incidents and field safety corrective actions

Ensure conformity of the device in accordance with the Quality Management System under which devices are manufactured before a device is released. PRRC shall verify the following for product sold in the EU: • Final product release • Sterilization process released • Nonconformities closed out

GSPR is compliant for investigational studies conducted within the EU.

1. Ensuring the correct conformity assessment of the device 2. Ensuring that the Technical Documentation and the EU Declaration of Conformity are drawn up and up-to-date 3. Ensuring that the Post Market Surveillance obligations are fulfilled 4. Ensuring that the vigilance, recall and Field Safety Corrective Actions obligations are fulfilled