Unique Device Identification (UDI) in detail
Master UDI Compliance and Implementation Across FDA, EU MDR/IVDR, and Global Medical Device Markets.
Unique Device Identification (UDI) has become a fundamental regulatory requirement for medical device manufacturers worldwide, supporting product traceability, patient safety, efficient recalls, and effective post-market surveillance. As regulatory frameworks continue to evolve across major markets—including the United States, European Union, and other global jurisdictions—organizations must understand and implement UDI requirements to ensure compliance and maintain market access.
This comprehensive 1-day training provides participants with a practical understanding of UDI regulations, including FDA requirements, EU MDR/IVDR expectations, EUDAMED registration, and global harmonization initiatives. Through real-world examples and implementation scenarios, learners will explore UDI components, device identification structures, labeling requirements, database registration, data management responsibilities, and the integration of UDI within quality and business processes.
Designed for professionals involved in regulatory affairs, quality management, product development, labeling, supply chain operations, software development, and medical device compliance, this course delivers the knowledge needed to successfully implement and maintain UDI programs within their organizations. Participants will gain a clear understanding of their responsibilities, key regulatory differences across markets, and best practices for achieving sustainable UDI compliance.
In this training course, you will:
- Familiarize with the regulations and learn the differences and additions in the respective legal requirements.
- The implementation of UDI in your company is shown on the basis of practical examples.
- In this way, you will acquire a compact overview to align your company with the new requirements of UDI.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is designed for professionals involved in the development, compliance, registration, labeling, traceability, quality management, and lifecycle management of medical devices, including:
- Regulatory Affairs Specialists and Regulatory Affairs Managers
- Quality Assurance Professionals and Quality Management Officers
- Medical Device Product Managers
- UDI Data Managers and Master Data Specialists
- Labeling, Packaging, and Artwork Management Teams
- Supply Chain, Operations, and Manufacturing Personnel
- Research & Development Leaders and Engineering Teams
- Software Developers working within the medical technology and digital health environment
- Managing Directors and Senior Leaders in medical technology companies
- EU Authorized Representatives and personnel from Competent Authorities and Supervisory Bodies
- Medical technology consultants, service providers, and compliance partners
- New hires and professionals transitioning into Medical Device Regulatory, Quality, or Compliance functions
- Basics and definitions "What is UDI?"
- Regulatory requirements for UDI, implementation
- Requirements for UDI in comparison
- IMDRF recommendations to UDI
- Ordinance on Medical Devices (MDR, 2017/745) and UDI
- Comparison of requirements from IMDRF, FDA, MDR
- Market surveillance and traceability
- Implementation of UDI
- Components UDI, UDI database, data carrier UDI
- Requirements for specific product groups
- UDI in the business process
- Quality checks UDI
- Overview of international UDI requirements
- Timeframes and deadlines for the introduction of UDI
- Illustration UDI in the quality management system
- Best practice in the introduction of UDI
For medical device manufacturers, a worldwide (for the respective defined target markets of the products) system for market surveillance and traceability of products is required in order to increase patient safety and also to simplify product recalls. This traceability must be guaranteed for every medical device and will in future be supported by a machine-readable code on the medical device and the associated data in the UDI databases (UDID) of the respective target markets. In these databases, the product-specific information is stored as required by law.
In addition to the FDA UDI requirements in the USA, the new Medical Devices Regulation (MDR, 2017/745) also makes the UDI requirements mandatory for manufacturers of medical devices in the EU. Countries such as South Korea have already implemented the UDI commitments since 2019, other countries such as China and Saudi Arabia are implementing the UDI commitments in 2022.
Every manufacturer of medical devices must deal with these requirements in a timely manner and implement them so that the respective local legal requirements are met. This is the only way to enable compliant sales. The implementation of these requirements is far-reaching, time-consuming and affects medical devices of all classes. The implementation according to MDR is risk-based. For all MDR-compliant, implantable devices (regardless of risk class) and Class III devices, the deadline was already May 2021. The deadlines for the next risk classes are 2023 and 2025. This approach to risk class-based implementation has so far been pursued by all countries that are already implementing the UDI requirements or will implement them in a timely manner. You will familiarize with these regulations and learn the differences and additions in the respective legal requirements. The implementation of UDI in your company is shown on the basis of practical examples. In this way, you will acquire a compact overview to align your company with the new requirements of UDI.
In this training course, you will:
- Learn about the new regulatory requirements for UDI in a compact manner.
- Get an overview of the implementation of UDI.
- Gain knowledge of your responsibilities and duties when introducing UDI in the business process.
Why UDI Training Remains Relevant
1. UDI is now a core compliance requirement globally
UDI is no longer a "future requirement"—it is embedded in regulatory frameworks across major markets, including:
- United States (FDA UDI system)
- European Union (MDR/IVDR and EUDAMED)
- Australia (TGA UDI program)
- Several other jurisdictions aligned with IMDRF traceability principles
Regulators continue to expand device traceability requirements, making UDI knowledge essential for Regulatory Affairs, Quality, Labeling, Supply Chain, and Product Management professionals.
2. EUDAMED makes UDI knowledge more important than ever
The European Commission has made the EUDAMED UDI/Device Registration module mandatory beginning May 28, 2026. Manufacturers must register device information and maintain UDI data to place products on the EU market.
This means companies need employees who understand:
- Basic UDI-DI
- UDI-DI
- UDI-PI
- EUDAMED registration
- Labeling requirements
- Data governance and maintenance
3. Traceability and post-market surveillance are growing priorities
UDI supports:
- Faster recalls
- Adverse event investigation
- Field Safety Corrective Actions (FSCAs)
- Supply-chain visibility
- Counterfeit prevention
These capabilities are becoming increasingly important as regulators demand stronger post-market surveillance and lifecycle management.
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy.
1. What is Unique Device Identification (UDI)?
UDI is a globally recognized system that enables the identification and traceability of medical devices throughout their lifecycle using standardized identifiers, labels, and regulatory databases. It supports patient safety, recalls, vigilance activities, and regulatory compliance.
2. Which regulations are covered in this course?
The training covers:
- IMDRF UDI guidance
- FDA UDI Final Rule and GUDID requirements
- EU MDR (2017/745) UDI requirements
- EUDAMED UDI registration requirements
- Selected international UDI implementation activities and trends
3. Will the course explain the differences between FDA and EU MDR UDI requirements?
Yes. Participants will learn the key similarities and differences between U.S. FDA and European MDR UDI requirements, including labeling, database registration, direct marking, Basic UDI-DI concepts, and data management expectations.
4. What are UDI-DI, UDI-PI, and Basic UDI-DI?
The course explains:
- UDI-DI (Device Identifier)
- UDI-PI (Production Identifier)
- Basic UDI-DI under EU MDR
- Their regulatory purpose, assignment, and practical use in labeling and databases.
5. Does the course cover EUDAMED registration?
Yes. Participants will gain an overview of EUDAMED UDI registration requirements, registration processes, data maintenance responsibilities, record updates, and legacy device considerations.
6. Are UDI database requirements discussed?
Yes. The training covers:
- FDA GUDID
- EUDAMED UDI/Device Registration
- Data submission requirements
- Data governance and maintenance responsibilities
- Database record updates and validation activities.
7. Will I learn how UDI affects quality management systems?
Yes. The course demonstrates how UDI integrates with:
- ISO 13485 requirements
- Technical documentation
- Risk management
- Change control
- Complaint handling
- Post-market surveillance and vigilance processes.
8. Does the training discuss UDI labeling requirements?
Yes. The course covers:
- Label and packaging requirements
- AIDC and HRI requirements
- Direct marking obligations
- Packaging hierarchy
- Barcode technologies and labeling best practices.
9. Are software and digital health products included?
Yes. The course addresses UDI requirements for Software as a Medical Device (SaMD), software version changes, software labeling, and software-specific UDI obligations under MDR.
10. Will reusable devices, implants, and procedure packs be discussed?
Yes. Special UDI requirements for:
- Implantable devices
- Reusable devices
- Systems and procedure packs
- Configurable devices are covered in detail.
11. Does the course include implementation guidance?
Yes. Participants will learn practical implementation strategies, including project planning, system integration, cross-functional collaboration, data management, and compliance roadmaps.
12. Will I learn about UDI timelines and compliance deadlines?
Yes. The training reviews risk-based implementation timelines and regulatory expectations for different device classes under FDA and EU MDR frameworks.
Course Structure FAQs
13. Is this course theoretical or practical?
The course combines regulatory theory with practical implementation examples, interactive discussions, exercises, and real-world case studies.
14. What training methods are used?
Participants learn through:
- Expert-led presentations
- Practical examples
- Knowledge checks and quizzes
- Interactive exercises
- Group discussions
- Case-study activities.
15. Is prior UDI experience required?
No. The course is suitable for both newcomers and experienced professionals seeking a comprehensive understanding of UDI requirements and implementation.
16. Who should attend this training?
The course is designed for professionals involved in:
- Regulatory Affairs
- Quality Assurance
- Product Management
- UDI/Data Management
- Labeling and Packaging
- Supply Chain and Operations
- R&D and Engineering
- Software Development
- Executive Management
- EU Representative and Competent Authority functions.
17. How long is the course?
The course is delivered as a 1-day instructor-led training program.
18. Is the course delivered live?
Yes. Training is delivered in a live virtual classroom environment with direct interaction between participants and the instructor.
19. Can participants ask questions during the course?
Yes. Participants are encouraged to engage with the instructor, discuss challenges, and ask questions throughout the training.
20. Will I receive a certificate?
Yes. Participants who attend at least 90% of the course will receive a TÜV SÜD Certificate of Attendance.
Train with Industry Experts
Learn from specialist instructors at TÜV SÜD Academy—recognized leaders with deep expertise in their fields. For over 35 years, our global network of 2,500+ trainers has delivered practical, real-world knowledge that you can apply immediately.
Our courses are continuously updated to reflect the latest regulatory changes and industry best practices, ensuring you gain relevant, up-to-date skills with every session.