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At Gefyra, we are fully committed to ensuring the safe and compliant commercialization of medical devices across the European market. While we currently operate as commercial agents — facilitating relationships between manufacturers and healthcare providers — we are in the active process of transitioning into full distributor operations.
Our approach is grounded in the principles and obligations outlined in Article 14 of Regulation (EU) 2017/745 (Medical Device Regulation, MDR). We are already implementing the required quality systems and standard operating procedures to ensure we meet — and exceed — regulatory expectations from day one of distributor activities.
Our Commitments Include:
Due Care: Acting responsibly when introducing devices to the market, with full awareness of applicable MDR requirements.
Compliance Verification: Ensuring products are CE marked, labelled appropriately, and accompanied by valid instructions for use before being made available.
Storage & Transport Oversight: Guaranteeing that storage and transportation conditions maintain product integrity, in accordance with manufacturer specifications.
Post-Market Surveillance Support: Promptly informing manufacturers of any suspected non-compliance, incidents, or adverse events.
Complaint & Non-Conforming Product Handling: Ensuring swift communication of complaints or safety concerns, and taking appropriate actions when a product is suspected to be defective, falsified, or non-compliant.
Record Keeping: Maintaining a robust system for tracking complaints, non-conformities, and recalls, and sharing this information with manufacturers and relevant authorities as needed.
Traceability: Implementing systems to document the distribution path of each device, in line with Article 25 MDR, to support any required recalls or field safety corrective actions.
We see regulatory compliance not just as a legal requirement, but as a foundation for trust. Our commitment to quality and transparency is central to how we operate, both now and as we grow into full distributor responsibilities.