Unique Device Identification (UDI) Management

What Is Unique Device Identification (UDI)?

Unique Device Identification (UDI) is a regulatory system established under EU MDR 2017/745 and IVDR 2017/746 to ensure the unique identification and traceability of medical devices and in vitro diagnostic medical devices throughout their lifecycle. The UDI system comprises the Basic UDI-DI, UDI-DI, and UDI-PI, supporting device identification, regulatory documentation, post-market surveillance, and efficient product traceability.

Manufacturers must assign appropriate UDI codes through designated issuing entities and ensure that the UDI carrier is correctly implemented on applicable device labels and packaging. Compliance with UDI requirements also supports accurate device registration in EUDAMED, strengthens supply chain traceability, and facilitates the identification of devices during vigilance and corrective actions.

Issuing Entities

The European commission has designated GS1, HIBCC and ICCBBA to issue UDI as mentioned in the MDR 2017/745 Article 27(2). The companies mentioned are already issuing UDI for US manufacturers.

List of designated authorities is mentioned:

• GS1
• HIBCC
• ICCBBA
• IFA GmbH

BASIC UDI-DI

Basic UDI-DI is intended to identify devices of the same group having the same intended purpose, risk classification and essential design characteristics and manufacturing process. It is the access key for the Eudamed database UDI Portal to access all the information related to the medical device.

The Basic UDI-DI will appear on the following:

• Notified body certificates or free sales certificate
• European Declaration of Conformity
• Technical Documentation
• Summary of Safety and (Clinical) Performance

The Basic UDI-DI does not appear on the packaging of a specific product. While the UDI-DI and UDI- PI will be placed on the device or device label and on the packaging of the medical device.

UDI = UDI-DI and UDI-PI

UDI-DI: Device identifier, identification of a specific device model. It is the part of the UDI which does not change, and remains constant for the entire device group.

UDI-PI: Production identifier. It is made of lot number, serial number, expiry date, manufacturing date, software identification etc. This part will not remain constant.

UDI Carrier

The UDI must be presented on the device and/or its packaging through a UDI Carrier, which contains both machine-readable and human-readable representations of the UDI.

Automatic Identification and Data Capture (AIDC)

The machine-readable component of the UDI Carrier, typically represented by a barcode or other scanning technology, enables rapid and accurate electronic capture of device identification information.

Human Readable Interpretation (HRI)

The human-readable component consists of the alphanumeric UDI information that can be read and entered manually when scanning technologies are unavailable.

Where feasible, both AIDC and HRI should be included on the device label. The UDI Carrier must remain legible and durable throughout the intended lifecycle of the device.

Labelling Requirements

In accordance with Annex VI, Part C, Section 4.7 of EU MDR 2017/745 and IVDR 2017/746, where significant space constraints prevent the inclusion of both the Automatic Identification and Data Capture (AIDC) format and the Human Readable Interpretation (HRI) on the device label, the AIDC format alone is considered sufficient. In such cases, the HRI is not required to be displayed on the label.

However, for devices intended for use outside healthcare facilities, including home-use devices, the HRI must be provided even where space limitations prevent the inclusion of the AIDC format. Manufacturers should ensure that the selected UDI carrier format remains compliant with the applicable regulatory requirements and maintains device traceability throughout the intended lifecycle.

MEDREG assist medical device and IVD manufacturers in implementing UDI requirements under EU MDR 2017/745 and IVDR 2017/746 to support device identification, traceability, labelling compliance, and EUDAMED registration.