Medical Device Labeling - ISO 15223-1:2021 & ISO 20417:2021

• Professionals in medical device development, regulatory affairs, and quality assurance.
• Auditors, consultants, and technical writers in the medical technology sector.
• Anyone responsible for creating, reviewing, or approving medical device labeling and IFUs.

Part 1: Foundations of Medical Device Labeling

• Introduction to ISO 15223-1:2021 and ISO 20417:2021
• History, scope, and terminology
• Labeling as part of risk management and usability engineering

Part 2: ISO 15223-1:2021 in Practice

• Symbol categories and updates
• 2025 Amendment: New definitions and EU REP symbol
• Interactive symbol exercises and decision tree application

Part 3: ISO 20417:2021 and Beyond

• Structure, key elements, and annexes
• ISO/DIS 20417 draft and anticipated changes
• Labeling content requirements and global alignment

Part 4: Global Compliance and Practical Application

• Comparison: EU MDR, US FDA, Japan PMDA
• Harmonization efforts and regulatory gaps
• Group discussions, case studies, and compliance strategies

Wrap-Up and Q&A

• Key takeaways and resources
• Final quiz and open discussion

Medical device labeling is a cornerstone of regulatory compliance, patient safety, and global market access. This 4-hour training session offers a deep dive into the practical application of the international standards ISO 15223-1:2021 and ISO 20417:2021, including the 2025 amendment to ISO 15223-1 and the upcoming revision of ISO 20417.

Participants will gain a thorough understanding of the structure, terminology, and regulatory context of both standards, with a strong emphasis on real-world implementation. The course includes interactive exercises, symbol identification activities, group discussions, and decision-making tools to help participants confidently apply compliant labeling practices across global markets.

This session also explores regional regulatory differences (EU, US, Japan), harmonization efforts, and the importance of ongoing review and updates to labeling strategies.

Deep Understanding of Labeling Standards

• Gain a comprehensive overview of ISO 15223-1:2021 and ISO 20417:2021, including the latest updates and amendments.
• Understand the structure, terminology, and regulatory context of both standards.

Practical Application of Symbols and Requirements

• Learn how to correctly apply standardized symbols using real-world examples and decision trees.
• Identify and avoid common labeling errors through interactive exercises and case studies.

Global Regulatory Awareness

• Compare labeling requirements across major markets (EU, US, Japan).
• Understand harmonization efforts and how to manage regional compliance challenges.

Engaging, Hands-On Learning

• Participate in quizzes, polls, and group discussions to reinforce learning and encourage knowledge sharing.
• Apply concepts through scenario-based exercises and mock label reviews.

Stay Ahead of Regulatory Changes

• Learn about the 2025 amendment to ISO 15223-1 and the draft revision of ISO 20417.
• Understand the importance of periodic labeling reviews and how to conduct gap analyses.

Learn from Experts and Peers

• Benefit from the experience of TÜV SÜD Academy instructors and industry peers.
• Share challenges and best practices in a collaborative learning environment.

• Implement up-to-date medical device labelling and accompanying information.
• You will get to know the essential contents of the ISO 15223-1:2021 and ISO 20417:2021 standards.
• Our overview of the contents allows you to identify the important topics of the standards and avoid unnecessary errors.
• Expanded Symbol Exercises: Matching, error spotting, and scenario-based symbol selection.
• Group Discussions: Share experiences and solutions on labeling challenges and global compliance.
• Visual Aids: Updated symbol visuals and real-world label mockups.
• Knowledge Checks: Quizzes and polls to reinforce learning and assess understanding.
• Benefit from the knowledge of our instructors, specialist lecturers of the TÜV SÜD Academy.

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.

The training session will be held through Microsoft Teams and you will receive all the information after your registration.

Certificate of participation from the TÜV SÜD Academy

• In order to be able to apply and implement the learning objectives directly, you should have the ISO 15223-1:2021 and ISO 20417:2021 standards at hand.
• Initial experience with the standards is helpful, but not a prerequisite.