EOF, EUDAMED, and GS1 Standards
At QC Analytics, we support organizations in navigating regulatory registration requirements and implementing Unique Device Identification (UDI) systems across European and national frameworks.
Our expertise covers EOF (Greece), EUDAMED (EU), and GS1 standards, ensuring your products are properly registered, traceable, and compliant with regulatory expectations.
EOF – Greek Regulatory Registration
The National Organization for Medicines (EOF) is the competent authority responsible for overseeing medical devices in Greece and ensuring their safety and compliance.
We support:
- Registration and notification of medical devices in Greece
- Preparation and submission of required documentation
- Compliance with national requirements and local procedures
- Communication with Greek authorities
- Registration of medical devices for manufacturers, distributors, and European representatives in the National Registry of Medical Devices of EOF 'GREMDIS'.
All medical devices must be registered with EOF before being placed on the Greek market, making this step essential for market access.
EUDAMED – European Database on Medical Devices
EUDAMED is the central European database established under MDR and IVDR regulations, providing a comprehensive overview of the lifecycle of medical devices in the EU.
We support:
- Actor and device registration in EUDAMED
- UDI/device data submission
- Management of certificates and regulatory information
- Compliance with MDR/IVDR requirements
EUDAMED enhances transparency, traceability, and coordination between EU member states and is becoming mandatory for manufacturers placing devices on the European market.
GS1 & UDI Implementation
Unique Device Identification (UDI) is a regulatory requirement under MDR and IVDR, enabling global traceability of medical devices.
We support the implementation of GS1 standards, including:
- Assignment of GTIN (UDI-DI) and Basic UDI-DI (GMN)
- Labeling and barcode requirements
- Data structuring and submission to EUDAMED
- Integration of UDI into internal systems
UDI systems provide a globally harmonized method for identifying devices, improving patient safety and supply chain efficiency.
Integrated Regulatory Support
We provide end-to-end support across all regulatory registration and identification requirements, within the framework of Greek Ministerial Decision ΔΥ8δ/Γ.Π. οικ/1348/2004, which governs the marketing and distribution of medical devices:
- Alignment of national (EOF) and European (EUDAMED) processes
- Integration of UDI into regulatory and quality systems
- Documentation preparation and submission management
- Ongoing compliance and lifecycle maintenance
This ensures your organization achieves efficient market access and sustained compliance.
The Next Steps
Contact QC Analytics to streamline your regulatory registrations and UDI implementation, ensuring your medical devices are compliant, traceable, and ready for the European market.