Glossary Term
Unique Device Identifier (UDI)
Definition
A Unique Device Identifier (UDI) is a system of numeric or alphanumeric codes used to uniquely identify a medical device throughout its lifecycle. The UDI system was developed to improve the traceability of medical devices, ensure patient safety, and enhance regulatory oversight. The UDI includes two key components: the Device Identifier (DI), which identifies the specific version or model of a device, and the Production Identifier (PI), which identifies the lot or batch number, serial number, expiration date, and other specific production details. This system is used by regulatory agencies such as the FDA to track devices through their entire lifecycle, from manufacturing to distribution to post-market surveillance.
Relevance to the MedTech Industry
The UDI system is a critical component in the MedTech industry for ensuring safety, regulatory compliance, and product traceability. It helps manufacturers meet the requirements of regulatory bodies like the FDA and EMA, which mandate the labeling of devices with UDIs to improve post-market surveillance, recall efficiency, and adverse event reporting. UDI plays a vital role in improving healthcare providers' ability to manage inventory, reduce medical errors, and ensure that patients are receiving the correct device. For the MedTech industry, UDI also facilitates regulatory submissions, assists in audits, and enables streamlined reporting in the event of device recalls or safety concerns.
Additional Information & Related Terms
Key Features of the Unique Device Identifier (UDI)
Device Identifier (DI): The DI is a fixed portion of the UDI that identifies the specific model, version, or configuration of the device. It is unique to the manufacturer’s product and remains constant across the product’s lifecycle.
Production Identifier (PI):The PI is the variable part of the UDI that identifies specific production details such as the lot or batch number, serial number, expiration date, or manufacturing date. This information is critical for tracking and traceability purposes.
Human-Readable and Machine-Readable Formats:The UDI must be both human-readable (e.g., printed on the packaging or device) and machine-readable (e.g., using barcodes or RFID tags). This dual format ensures that healthcare providers can quickly access device information for patient safety and inventory management.
Global Compatibility:The UDI system is designed to be compatible with global standards, ensuring that devices can be tracked and identified across different regions. This global approach helps facilitate international trade and regulatory compliance.
Integration with Databases:UDIs are integrated with centralized databases such as the FDA’s Global Unique Device Identification Database (GUDID), allowing healthcare providers, regulatory bodies, and manufacturers to access up-to-date device information.
Related Terms
Global Unique Device Identification Database (GUDID): A database maintained by the FDA that contains information about medical devices with UDIs, enabling manufacturers, healthcare providers, and patients to access device details.
UDI Labeling: The practice of labeling medical devices with a unique device identifier, which includes a Device Identifier (DI) and a Production Identifier (PI), as required by regulatory bodies.
Medical Device Regulations (MDR): Regulations governing medical devices in regions like the EU, which require the use of UDIs for product traceability and safety.
Device Identifier (DI): The part of the UDI that identifies a specific device model, version, or configuration.
Production Identifier (PI): The part of the UDI that provides details such as the lot number, serial number, and expiration date, used for device tracking and traceability.