Unique Device Identifier (UDI): Traceability of Medical Devices

What are the Features of the System?

Unique Device Identifier (UDI)

The Unique Device Identifier (UDI) is a unique identifying number for each medical device and is a system developed to ensure the traceability of medical devices, increase safety and improve efficiency in the healthcare system. In the European Union, the use of UDI is mandatory under the EU-MDR (Medical Device Regulation) and EU-IVDR (In Vitro Diagnostic Device Regulation). The UDI system facilitates the tracking of devices throughout their lifecycle and allows for the accurate collection of all product-related information.

Definition and Structure of UDI

UDI is a code or number used to identify a medical device or in vitro diagnostic device, uniquely marking the device. The UDI usually consists of two parts:

• UDI-DI (Device Identifier): This is the unique identifier of the device. It contains information about the manufacturer or model of the medical device. The UDI-DI represents an identification number of the device set by the manufacturer and ensures that each device is different.
• UDI-PI (Production Identifier): This specifies the manufacturing details of the device, for example the date of manufacture, serial number, lot number or expiry date of the device. The UDI-PI is used to track a specific production batch of the device.

A UDI is usually located on the device in the form of a barcode or RFID (Radio Frequency Identification) tag. This allows healthcare providers and users to quickly identify the device.

Importance and Benefits of UDI

The UDI system improves safety and quality control processes for medical devices by enabling more efficient and safer monitoring of medical devices. The main benefits of this system are as follows:

a. Increased Traceability and Safety

• Traceability: UDI ensures that each medical device has a unique identification number. This way, every stage of the devices can be traced, from manufacturing to medical use and recall. Potential safety risks, the manufacturer of the device, date of manufacture and other important information can be quickly identified.
• Rapid Recalls: When any safety or quality issues with medical devices are detected, UDI allows for a much faster and more efficient recall of the device. This helps to minimize potential risks.

b. Clinical Safety

The UDI system allows to quickly identify problems that may arise during the use of devices. The correct implementation of UDI makes it easier for healthcare providers to review the history of devices and identify the source of possible malfunctions or errors. This increases the safety of patients.

c. Effective Inventory Management and Logistics

Healthcare providers can use the UDI system for the proper management and storage of medical devices. The location of devices in inventory and their utilization can be tracked, enabling efficient management of resources. This can provide information on the expiry date and duration of use of the devices and facilitate stock management.

d. Health Data Quality and Transparency

UDI improves device data collection and reporting. With UDI, healthcare professionals can access accurate and transparent information about devices. In addition, the use of UDI enables better health data analysis.

e. Legal Compliance and Regulations

European Union regulations such as EU-MDR and EU-IVDR have made it mandatory for medical devices to use UDI. This makes it easier for manufacturers to comply with regulations. UDI helps manufacturers and distributors fulfill legal requirements and quickly provides the information needed for audits.

Use of UDI in the European Union

In the European Union, the EU-MDR and EU-IVDR regulations mandate the use of UDI. These regulations aim to improve the traceability and safety of medical devices. Manufacturers must create a UDI number for each device and place this number on product labeling before placing their devices on the market.

a. EU-MDR and UDI

The EU-MDR mandates UDI to improve the safety of medical devices and reduce the impact of adverse events. When medical devices are classified according to specific classes (I, IIa, IIb, III), UDI requirements will also be subject to specific rules. For high-risk devices, the UDI should have more detailed information.

b. EU-IVDR and UDI

EU-IVDR has similarly mandated the use of UDI for in vitro diagnostic devices. The UDI requirement is also applied to ensure the traceability and safety of in vitro diagnostic devices.

c. UDI and EUDAMED

EUDAMED (European Database on Medical Devices) is the central database for the traceability of medical devices and in vitro diagnostic devices in the European Union. UDIs are registered in the EUDAMED database, where they are traceable throughout the lifecycle of the devices. EUDAMED collects UDIs in a centralized location and facilitates processes such as device recalls and safety reporting.

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