What is UDI?
The Unique Device Identification (UDI) system assigns a unique code to every medical device. This code serves as a digital fingerprint, enabling traceability and simplifying compliance with MDR and IVDR regulations.
UDI consists of two parts:
- Device Identifier (DI): A static portion that identifies the manufacturer and device type.
- Production Identifier (PI): A dynamic portion that provides information such as batch number, serial number, and expiration date.
Why is UDI Critical for EUDAMED?
UDI is a foundational element of EUDAMED because it ensures that every device can be uniquely identified across its lifecycle. The UDI/Device Registration Module centralizes this data, supporting key objectives such as:
- Enhanced Traceability: UDI allows stakeholders to track devices from production to post-market use.
- Improved Recall Management: UDI simplifies the identification of affected devices during recalls.
- Increased Transparency: Patients and healthcare professionals can access detailed information about devices.
How UDI Supports Compliance
UDI streamlines regulatory processes for manufacturers and authorities by:
- Standardizing device identification across the EU.
- Reducing errors in device registration and tracking.
- Facilitating data sharing among stakeholders via the EUDAMED database.
To learn more about how data is shared within EUDAMED, refer to EUDAMED Stakeholders.
Benefits of UDI for Manufacturers and Patients
For Manufacturers
- Streamlined compliance with MDR and IVDR.
- Improved supply chain management.
- Reduced administrative burden through standardized processes.
For Patients
- Increased access to safety information.
- Greater confidence in the quality of medical devices.
- Faster response times during recalls.