The Egyptian Drug Authority (EDA) has established a Unique Device Identification (UDI) system to standardize how medical devices, their accessories, and in vitro diagnostics (IVDs) are identified throughout their lifecycle in the Egyptian market. This guideline outlines the requirements, implementation, and regulatory expectations for UDI.

Purpose and Scope

The guideline aims to:

• Enhance patient safety and care by enabling accurate identification and tracking of medical devices.
• Support traceability, including during adverse events, recalls, and field corrective actions.
• Improve data capture and transparency across clinical and supply chain systems.

It applies to all medical devices, accessories, and IVDs entering the Egyptian market, both domestic and imported—excluding those used solely for research, investigational purposes, or custom-made devices. Manufacturers, agents, importers, distributors, and healthcare providers are all subject to the guideline’s requirements.

Key UDI Requirements

1. UDI Components
   The UDI consists of two parts:
   • UDI-DI (Device Identifier): A unique code that identifies a specific version or model of a device within the manufacturer’s portfolio.
   • UDI-PI(s) (Production Identifier): Variable identifiers such as lot/batch number, serial number, expiration or manufacture dates.
   • These elements must be encoded in a globally unique structure and comply with GS1 standards.
2. Placement and Format
   The UDI must appear on the device label and all higher levels of packaging in both:
   • Human-readable interpretation (HRI)
   • Automatic Identification and Data Capture (AIDC) formats (e.g., barcodes)
   • AIDC should be clearly identifiable and scannable throughout the device’s lifecycle.
   • If RFID technology is used, a corresponding barcode must still be present.
3. Direct Marking (DM)
   Direct marking of reusable devices is required if feasible and permanent, ensuring the UDI remains readable throughout the device’s use.
   If DM is impractical due to safety or performance concerns, exemptions may be requested.
4. UDI Lifecycle and Changes
   A new UDI-DI must be assigned when significant changes affect device identification or traceability such as changes in brand name, model, packaging, or critical clinical attributes.
5. UDI Database and Reporting
   Manufacturers or their agents must submit and maintain UDI data in the Egyptian UDI Database, including:
   • GTIN and device identifiers
   • Manufacturer and agent contact information
   • Brand/trade name and device description
   • Device risk class and catalog number

Production identifiers (e.g., lot, expiration)

This database supports regulatory surveillance and public health initiatives, with key fields publicly accessible.

Additional Considerations

The guideline also covers:

• Software as a Medical Device (SaMD): UDI assignment for software shipped on physical media and UDI display on accessible screens.
• Package and Kit Structures: UDI assignment and relationships among primary, packaging, and component UDIs within multi-item kits.
• Request for Exceptions: Manufacturers can apply for exceptions or alternative methods if standard UDI requirements are not feasible, subject to justification and EDA review.

Impact and Importance

The UDI system enhances the regulatory framework for medical devices in Egypt by enabling:

• Efficient device traceability across distribution and clinical use
• Better management of recalls and safety corrective actions
• Improved quality and transparency in post-market surveillance

By aligning with international standards such as GS1 and UDI systems used by mature regulators globally, the EDA UDI guideline supports both patient safety and regulatory clarity for industry stakeholders operating in Egypt.