Among additional duties, the main responsibilities are the ones mentioned on Article 15 of the
EU MDR 2017/745/EC:
- Conformity of the product device 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)
Masqué
FARIS Thomas
Among additional duties, the main responsibilities are the ones mentioned on Article 15 of the
EU MDR 2017/745/EC:
- Conformity of the product device to the Medical Device Regulation and Quality
Management System
- Conformity of the Technical Documentation and EU Declaration of Conformity