Training Features

Unique Device Identification (UDI)

Join our training to master Unique Device Identification (UDI) requirements, understand global regulatory obligations, and gain practical insights for implementing UDI systems to ensure compliance and maintain market access.
Format

Virtual Training

Level

Basic

Date

2 December 2025

Time

14:00 - 18:00 CET

Duration

4 hours

Trainer

Agnieszka Schreiber

Certifcate

Certificate included

Price

€ 595 or equivalent currency

Understanding and Implementing UDI: Global Requirements and Practical Guidance for Medical Device Manufacturers

The Unique Device Identification (UDI) system is a key regulatory requirement under the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746. It enhances traceability, improves post-market surveillance, and ensures patient safety by providing a standardized system for identifying medical devices and in vitro diagnostics. 

Led by Agnieszka Schreiber, this training helps medical device and IVD professionals understand UDI requirements and how to implement them effectively. This training covers the UDI system structure, labeling requirements, EUDAMED registration, and practical steps for compliance.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
To enhance patient safety and streamline product recalls, medical device manufacturers are required to implement a global system for product traceability and market surveillance, tailored to the legal requirements of their target markets. This system is known as Unique Device Identification (UDI), and it ensures that every medical device can be clearly identified through a machine-readable code and corresponding data stored in national or regional UDI databases (UDID).

Compliance with UDI regulations is mandatory for all manufacturers and essential for maintaining access to global markets. These regulations are extensive, time-consuming to implement, and apply to all device classes. Under the EU Medical Device Regulation (MDR), implementation is risk-based, with deadlines phased by device class: implantable devices and Class III devices had to comply by May 2021, followed by Class II and I devices in 2023 and 2025 respectively. This stepwise, risk-based approach is also being adopted by other regulatory authorities worldwide.

In this training, you will become familiar with the key requirements of UDI systems across different jurisdictions. You'll learn how to identify regulatory differences, understand the legal obligations in each market, and gain practical insights into how UDI can be implemented within your organization. Through real-world examples, you’ll develop a clear and concise understanding of how to prepare your company for UDI compliance.
Key Learning Objectives
  • Understand the UDI system and its role in MDR/IVDR compliance
  • Learn the structure of UDI, including UDI-DI, UDI-PI, and Basic UDI-DI
  • Gain knowledge of UDI issuing entities (GS1, HIBCC, ICCBBA) and labeling requirements
  • Understand the process of submitting UDI data to EUDAMED
  • Learn how UDI integrates into Quality Management Systems (QMS) and technical documentation
  • Recognize the role of UDI in post-market surveillance and vigilance reporting
  • Identify common challenges in UDI implementation and best practices for compliance
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
The training sessions will take place on 2 December 2025, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the December training date is not suitable, additional sessions will be held in 2026. More information will be shared soon.
Who Should Attend?
  • Regulatory Affairs professionals responsible for UDI compliance 
  • Quality Assurance (QA) managers and personnel 
  • Labeling and packaging teams responsible for UDI implementation 
  • Supply chain, manufacturing, and distribution professionals 
  • IT and data management teams handling UDI submissions to EUDAMED
  • Post-Market Surveillance (PMS) and vigilance professionals 
  • Anyone involved in the implementation and maintenance of UDI in medical device and IVD companies.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework for UDI: Overview of UDI requirements under MDR and IVDR, differences between EU UDI and UDI requirements in other markets (e.g., US FDA), and the role of UDI in traceability and post-market surveillance. 
  • UDI System Structure & Requirements: Basic UDI-DI and how it links to regulatory documentation, UDI-DI (Device Identifier) vs. UDI-PI (Production Identifier), and how UDI applies to different types of devices and packaging levels. 
  • UDI Issuing Entities & Standards: GS1, HIBCC, and ICCBBA: selecting the right issuing entity, UDI formats, and considerations for software as a medical device (SaMD).
  • UDI Labeling & Data Submission to EUDAMED: Labeling requirements and placement of UDI on packaging and devices, UDI data attributes and submission process in EUDAMED, and compliance deadlines and transition periods. 
  • Integration of UDI into Quality Management Systems (QMS): How UDI impacts documentation, traceability, and record-keeping, ensuring consistency between UDI, technical documentation, and regulatory submissions, and handling UDI-related changes in QMS processes.
  • Post-Market Surveillance & UDI Compliance: Role of UDI in incident reporting and field safety corrective actions (FSCAs), how UDI enhances post-market surveillance and recall processes, and best practices for ongoing UDI compliance and data.
  • Challenges & Best Practices for Implementation: Common pitfalls and how to avoid them, industry case studies, lessons learned, and preparing for Notified Body and Competent Authority inspections related to UDI.

Flexible Online UDI Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with hands-on industry experience, gaining practical insights and a clear understanding of UDI requirements and implementation under the EU MDR and IVDR.

Expert-Led UDI Training for Practical Compliance

Meet the Trainer

Agnieszka Schreiber

Agnieszka specializes in regulations and technical aspects of medical devices, focusing on Unique Device Identification, GS1 standards, technical documentation, risk management, and global regulatory strategies at Qserve, emphasizing practicality and customer engagement.