Basic UDI-DI and UDI-DI: What Each Identifier Does and Where It Is Checked

The European Union's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 establish a comprehensive Unique Device Identification (UDI) system. This system is fundamental for device traceability, post-market surveillance, and regulatory compliance. It relies on two distinct identifiers: the Basic UDI-DI and the UDI-DI, each serving a specific purpose within the regulatory framework.

#The Unique Device Identification (UDI) System in the EU

The UDI system was introduced to enhance the identification and traceability of medical devices placed on the EU market. This system aims to improve patient safety, facilitate market surveillance by competent authorities, and enable rapid response to safety issues. It comprises the UDI-DI and the UDI-PI, but the overarching identifier for device models is the Basic UDI-DI.

According to Article 27(1) MDR and Article 24(1) IVDR, the UDI system enables the identification and traceability of devices. It requires manufacturers to assign and maintain UDI for their devices. For distributors and importers, understanding these identifiers is essential for verifying device compliance and for interacting with the EUDAMED database.

#Basic UDI-DI: The Primary Key for Device Models

The Basic UDI-DI, as defined in Article 2(14) MDR and Article 2(13) IVDR, is the primary identifier of a device model. It is the main key used in the EUDAMED database and in relevant documentation to identify a device model. It links devices that share the same intended purpose, risk class, essential design, and manufacturing characteristics.

#Characteristics and Purpose of the Basic UDI-DI

• Device Grouping: The Basic UDI-DI groups devices of the same type. For example, all variants of a particular surgical instrument that fall under the same risk classification and design principles would share the same Basic UDI-DI, regardless of minor variations in size or packaging.
• EUDAMED Registration: The Basic UDI-DI is a mandatory data element for device registration in EUDAMED, as stipulated in Article 29(1) MDR and Article 26(1) IVDR. It acts as the primary key for all device-related information in the database, including certificates, declarations of conformity, and summary of safety and clinical performance (SSCP).
• Documentation: It must be present on relevant documentation such as the EU Declaration of Conformity (Annex IV MDR, Annex IV IVDR), the certificate of conformity (Article 56 MDR, Article 53 IVDR), and the technical documentation (Annex II MDR, Annex II IVDR).
• No Direct Labelling: The Basic UDI-DI does not appear on the device label or its packaging. It is a regulatory identifier, not a consumer or supply chain identifier.

Manufacturers are responsible for assigning and maintaining the Basic UDI-DI. Changes to a Basic UDI-DI are required only if there is a major change to the device, affecting its intended purpose, risk class, or fundamental design and manufacturing characteristics. This would typically necessitate a new registration in EUDAMED.

#UDI-DI: The Specific Device Identifier

The UDI-DI (Device Identifier) is defined in Article 2(15) MDR and Article 2(14) IVDR as a specific numerical or alphanumeric code specific to a model of device. It provides a more granular level of identification than the Basic UDI-DI.

#Characteristics and Purpose of the UDI-DI

• Model Specificity: While the Basic UDI-DI identifies a device model family, the UDI-DI identifies a specific version or model of a device. For example, different sizes or coating variations of the same surgical instrument (which share a Basic UDI-DI) would each have their own UDI-DI.
• Labeling Requirement: The UDI-DI, together with the UDI-PI (Production Identifier), forms the full UDI carrier. The UDI carrier, in both human-readable and AIDC (Automatic Identification and Data Capture) formats, must be placed on the device label and on all higher levels of packaging, as specified in Part C of Annex VI MDR and Part C of Annex VI IVDR.
• Traceability: The UDI-DI is critical for traceability in the supply chain and for internal hospital logistics. It enables specific device models to be identified and tracked from manufacture through distribution to the end-user.
• Relationship to Basic UDI-DI: Each UDI-DI is linked to one Basic UDI-DI. Multiple UDI-DIs can share the same Basic UDI-DI, reflecting different configurations or packaging of the same core device model. This relationship is crucial for data consistency in EUDAMED.

Importers and distributors must ensure that devices they place on the market bear the UDI carrier on their labels and packaging. They are also expected to verify that the UDI-DI listed on the device matches the information in EUDAMED when that module becomes fully functional. The status of EUDAMED modules becoming mandatory has evolved in stages; readers should confirm the current scope with their national competent authority.

#Key Differences Summarised

| Feature | Basic UDI-DI The UDI system is designed for the European market, improving traceability and safety of medical devices. Importers and distributors must understand their roles in verifying Basic UDI-DI and UDI-DI information. These identifiers are crucial for seamless device registration and data management in EUDAMED. Ensuring accurate UDI information is a shared responsibility across the device supply chain.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.