Unique Device Identification (UDI) in detail

• Manager Regulatory Affairs
• Quality Management Officer, Head of Research & Development, Managing Director in Medical Technology Companies
• Software developers in the medical technology environment
• EU representatives and staff in supervisory authorities
• Service provider in the field of medical technology

• 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.

• The new regulatory requirements for UDI are conveyed to you in a compact manner.
• You will get an overview of the implementation of UDI.
• You will gain knowledge of your responsibilities and duties when introducing UDI in the business process.

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.

Certificate of participation from the TÜV SÜD Academy