The global medical device industry is increasingly data-driven, and nowhere is that more evident than in device identification. The Unique Device Identification (UDI) system, introduced under major global regulatory frameworks, was designed to enhance traceability, post-market surveillance, and patient safety.
By uniquely identifying each medical device and its production details, regulators and manufacturers can trace devices through the supply chain, identify affected batches in recalls, and ensure better transparency in the market.
At the center of the EU’s approach to UDI lies the Basic UDI-DI, the cornerstone of device identification under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Without it, manufacturers can’t complete EUDAMED registration, notified body certification, or conformity documentation.
Who should care?
- Manufacturers preparing for MDR or IVDR submissions
- Regulatory affairs professionals managing device portfolios
- Quality and compliance teams responsible for UDI data and documentation
Understanding how to correctly structure and assign a Basic UDI-DI isn’t just a regulatory necessity, it’s a compliance strategy that supports smoother submissions and ongoing data integrity.
What Is a Basic UDI-DI?
Under Article 2(15) of the MDR, the Basic UDI-DI is defined as “the primary identifier of a device model that groups all devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.”
In other words, it represents a device family; not a single product.
Here’s how it fits within the broader hierarchy of identifiers:
| Identifier | Level | Purpose |
|---|---|---|
| Basic UDI-DI | Family/group | Links devices with the same intended purpose, risk class, and design. Required for registration and certificates. |
| UDI-DI | Device-specific | Unique to each individual device or model; appears on the label and packaging. |
| UDI-PI | Production | Includes manufacturing details (batch number, serial number, expiry date). Used for traceability and recalls.This difference is what makes regulatory intelligence in medical devices so valuable. It bridges the gap between what’s changing and what your company needs to do next. |
The Basic UDI-DI is not printed on the label but serves as the “key access point” for all information related to that family in EUDAMED, and appears on notified body certificates and Declarations of Conformity (DoCs).
Think of it this way: The Basic UDI-DI groups devices into families, the UDI-DI identifies each specific device, and the UDI-PI pinpoints when and how it was produced.
Structure and Format
The structure of a Basic UDI-DI depends on the issuing agency, typically GS1, HIBCC, ICCBBA, or IFA. Each agency provides rules governing the identifier’s length, character format, and prefixes.
Although formats differ, the same underlying rule applies: the identifier must uniquely and consistently represent a family of devices.
Example:
- Basic UDI-DI (Family): (01)1234567890ABCDE
- UDI-DI (Specific Device): (01)1234567890ABCDEF1
Common mistakes:
- Reusing identifiers for unrelated device families
- Failing to assign a new Basic UDI-DI when design or purpose changes
- Misunderstanding grouping rules for accessories or software modules
How Basic UDI-DI Relates to UDI-DI and UDI-PI
When and How to Assign a Basic UDI-DI
Manufacturers must assign a Basic UDI-DI before submitting a device for conformity assessment or registration.
A single Basic UDI-DI can cover multiple products only if they share:
- The same intended purpose
- The same risk class
- The same essential design and manufacturing characteristics
When to Create a New Basic UDI-DI
Manufacturers must assign a new Basic UDI-DI if there’s a:
- Change in intended purpose (e.g., diagnostic to monitoring)
- Change in risk class
- Significant design or manufacturing change
Every assignment should be documented in the technical file and linked to your internal systems, such as Regulatory Information Management Systems (RIMS) or Product Lifecycle Management (PLM) tools.
Regulatory reference: MDR Annex VI, Part C provides detailed requirements for UDI assignment and documentation.
Regulatory Submission and EUDAMED Requirements
The Basic UDI-DI plays a central role across EU regulatory submissions and documentation.
It appears in multiple key places:
- EUDAMED Registration: Acts as the anchor for the device family, connecting device data and certificates.
- Notified Body Certificates: Identifies the product family evaluated during conformity assessment.
- Declarations of Conformity: Each DoC must reference the appropriate Basic UDI-DI.
- Technical Documentation: Links all related design, testing, and labeling data.
Within EUDAMED, you’ll be required to provide:
- Basic UDI-DI code and issuing agency
- Device group name, trade name, and risk class
- Associated certificates and documentation
Common challenges:
- Managing multiple product families with overlapping identifiers
- Maintaining consistency across global submissions
- Ensuring data synchronization between EUDAMED, QMS, and internal records
Tip: Define ownership early. Assign one team or system as the “single source of truth” for all UDI-related data to reduce duplication errors.
Global Context and Comparison
The Basic UDI-DI is unique to the European regulatory framework, but other markets have implemented similar systems with slight variations.
| Region | Regulatory Authority | Identifiers Used | Key Difference |
|---|---|---|---|
| European Union | EU MDR/IVDR | Basic UDI-DI, UDI-DI, UDI-PI | Includes a family-level identifier (Basic UDI-DI). |
| United States | FDA | UDI-DI, UDI-PI | No Basic UDI-DI concept; identifiers apply to individual devices. |
| China | NMPA | UDI-DI, UDI-PI | Similar to FDA; no family grouping identifier. |
| Canada | Health Canada | UDI-DI, UDI-PI (in development) | Framework aligning with IMDRF guidance. |
For manufacturers operating globally, the challenge is to harmonize data across systems that don’t always align. The EU’s Basic UDI-DI structure can serve as a valuable organizing principle for managing product families across multiple jurisdictions.
Best Practices and Common Pitfalls
Managing UDI data requires coordination between regulatory, quality, and IT teams. A well-defined internal strategy helps ensure compliance and data accuracy across all systems.
Best Practices
- Develop a clear internal SOP for assigning and maintaining Basic UDI-DIs
- Integrate UDI data into RIMS, QMS, and PLM systems to prevent errors
- Train teams on when new identifiers are needed
- Train teams on when new identifiers are needed
Common Pitfalls
- Assigning the same Basic UDI-DI to unrelated device groups
- Failing to update certificates after product changes
- Managing identifiers manually in spreadsheets rather than centralized tools
“UDI management isn’t just a compliance task, it’s a data integrity challenge. Consistency across systems is the foundation for regulatory success.”
Conclusion
The Basic UDI-DI may look like a string of characters, but it carries enormous regulatory weight. It’s the central connector between your devices, technical documentation, and regulatory submissions under MDR and IVDR.
By proactively managing Basic UDI-DIs, and ensuring consistent data across all systems, manufacturers can streamline EUDAMED registration, simplify audits, and build a stronger foundation for global UDI compliance.
Learn how RegDesk helps automate and manage UDI compliance across regions by simplifying submissions and ensuring consistency for global device manufacturers.
