- Conformity of the product to the Medical Device Regulation and Quality Management System
- Conformity of the Technical Documentation and EU Declaration of conformity
- Compliance with Post-Market Surveillance (PMS) following Article 10(10)
- Compliance with the Vigilance Reporting obligations (Article 87 to 91)
- For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)