ERTRIAGE is underpinned by rigorous standards for quality, safety, and responsible healthcare practices. As part of this commitment, we align with the Greek Ministerial Decision ΔΥ8δ/Γ.Π. οικ.1348/2004 — known as YA 1348/2004, which defines the principles and guidelines for the good distribution practice (GDP) of medical devices.

What is YA 1348/2004?

YA 1348/2004 is a Greek regulatory framework that sets out good practice principles for the handling, storage, distribution, and traceability of medical devices. It applies to businesses involved in:

• Importing and distributing medical devices
• Storage and logistics operations related to medical technology
• Commercialization and supply of medical and diagnostic instruments

This framework helps protect device integrity, quality, and patient safety throughout the supply chain.

Why It Matters for Medical Technology

Adherence to YA 1348/2004 demonstrates that an organization:

• Maintains documented and controlled processes for storage and distribution
• Preserves quality and integrity of medical technology products
• Ensures traceability across device handling and movement
• Implements structured procedures to manage inventory, recalls, and returns

Compliance with these principles boosts operational credibility, supports engagement with healthcare providers, and enhances trust with regulatory and institutional partners.

ERTRIAGE and Good Distribution Practice

As a medical technology provider, ERTRIAGE recognizes the importance of responsible device management and distribution governance.

Although ERTRIAGE products are primarily software-driven clinical and operational tools, we structure our development, documentation, and supply processes in alignment with internationally recognized quality and distribution expectations — including:

• Technical governance aligned with GDP principles
• Secure and controlled delivery of software components
• Traceability and audit logging of software releases and updates
• Documentation practices compatible with regulated medical device supply environments

This approach ensures our solutions are not just advanced in technology — they are engineered for operational excellence and regulatory confidence.

Supporting Institutional Trust

Compliance with good distribution practices such as those described in YA 1348/2004 has become a baseline expectation in healthcare ecosystems for:

• Public procurement evaluations
• Hospital partnerships
• EU healthcare tenders
• Regulatory due diligence

Aligning with these principles reinforces ERTRIAGE’s credibility as a trusted provider in clinical and operational healthcare technology markets.

Evolving with the Regulatory Landscape

The regulatory framework for medical device distribution continues to evolve. In 2025, a revised Greek ministerial decision (Δ3(α)4822/2025) has been introduced to modernize and align distribution practice expectations with updated EU medical device regulations.

ERTRIAGE remains committed to adapting our governance and quality practices in step with these legislative developments, ensuring our customers and partners always benefit from state-of-the-art compliance and operational integrity.