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

Employees in the areas of development and approval of medical devices. This includes, in particular, all areas of quality assurance. We also address our training to auditors and consultants in the field of medical technology.

• Basics of the ISO 15223-1:2021 standard
  • History, development and terms
  • Innovations
• Basis of the ISO 20417:2021 standard
  • Labelling of medical devices – A symbol for everyone?!
  • History, development and terms
  • Structure and innovations
• Time to exchange experiences

The labeling of medical devices is a crucial topic in the field of medical technology. Recently, two important standards have been introduced which provide valuable guidance. ISO 15223-1:2021 and ISO 20417:2021 lay down the foundation for determining and meeting regulatory requirements. These standards outline what the labeling of medical devices should look like and what information the manufacturer should provide. They are considered the "state of the art" for markings and instructions for use. ISO 20417 will replace the existing harmonized standard EN 1041, and ISO 15223-1:2021 is the successor to the 2017 edition of ISO 15223-1.

This training session provides an overview of ISO 15223-1:2021 and ISO 20417:2021. We will focus on key points, including the changes and updates from both standards, clarify various terms, and highlight the most important topics. You will also learn about the new symbols introduced in ISO 15223-1 and the topics addressed in ISO 20417. The session will conclude with an opportunity to discuss any questions or concerns you may have with our experienced instructor.

• 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.
• 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.