What is a Unique Device Identification?

What Is a Unique Device Identification (UDI)?

The Unique Device Identification (UDI) is a unique alphanumeric or numeric code that helps to identify and track medical devices throughout their lifecycle, from manufacturing to patient use. It aims to enhance patient safety, streamline device recalls, and improve overall device traceability. 

The UDI system encompasses several critical components and requirements for medical device manufacturers. The manufacturers must determine if their product qualifies as a medical device according to the criteria of the regulatory consulting. Once confirmed, device labellers, typically manufacturers, are obliged to include a UDI on product labels and packaging, with direct marking on the device itself for reusable items. This UDI information must be submitted to the Global Unique Device Identification Database (GUDID), consisting mainly of the Device Identifier (DI). 

Key Components of a Unique Device Identification (UDI)

The UDI comprises two parts:

the DI: a fixed part of the UDI that helps in identifying the labeller and the device model.

the Production Identifier (PI): a variable part of the UDI that helps in identifying one of more of the following for a device:

UDIs must be presented in both plain text and machine-readable form. Standardized date formats and unique codes are required to ensure compliance. Implementation occurs in phases, covering lower-risk devices last. Exceptions and alternatives can be requested, subject to FDA approval. Submission to GUDID is necessary, and AccessGUDID offers a searchable database for accessing device identification information, benefiting various stakeholders in the healthcare industry.

Benefits of a UDI System

A UDI system can support in the overall traceability of medical devices. However, it provides additional benefits to various stakeholders within the pharmaceutical and healthcare industry. For example, an UDI system facilitates more meticulous and accurate reporting, reviewing, and evaluation of adverse events (AEs) related to devices so that they can be rectified efficiently. It supports healthcare professionals in rapidly identifying devices to obtain critical information about the device attributes in order to reduce medical errors. It can potentially support post-market safety surveillance for devices as it enables a more clear and standard way of documenting devices various sources such as electronic health records (EHRs), clinical information systems, registries etc.

The UDI system is supported by the final UDI which is the regulatory framework for the system’s implementation. The advantages of a UDI system can only be leveraged if the UDK system is properly implemented and adopted by different medical device-related stakeholders.

DDReg Capabilities

DDReg has supported its customers is overcoming regulatory challenges and complexities that are associated with medical devices and combination products:

Registration of device establishment

US FDA premarket notification 510(k) or premarket approval (PMA)

Medical device listing

Investigational Device Exemption (IDE)

Medical Device Reporting (MDR)

Quality System (QS) regulation

Labelling requirements

Import license and/or medical device registration

Post approval changes