European Database on Medical Devices: Understanding and Implementing EUDAMED Requirements
Mastering EUDAMED for MDR/IVDR Compliance
This 1-day training course provides a comprehensive introduction to the European Database on Medical Devices (EUDAMED), a cornerstone of regulatory compliance under MDR (EU) 2017/745 and IVDR (EU) 2017/746. EUDAMED is designed to enhance transparency, traceability, and coordination across the EU medical device market.
Participants will gain practical knowledge on how to navigate and implement EUDAMED requirements, including the registration of economic operators, device data entry, and UDI management. Whether you're a manufacturer, authorized representative, importer, distributor, or regulatory professional, this course will equip you with the knowledge and tools to meet EUDAMED requirements confidently and efficiently.
By attending this course, you will:
- Understand the structure and purpose of EUDAMED and its role in EU regulatory frameworks.
- Learn how to register economic operators and apply for the Single Registration Number (SRN).
- Gain clarity on UDI requirements and how to manage device data entry.
- Explore the interconnectivity of EUDAMED modules and their impact on quality management systems.
- Know about the necessary maintenance and care of the data and the deadlines.
Now is the time to familiarize yourself with EUDAMED and gain the knowledge necessary to navigate its requirements confidently. Our specialized training course equips you with the skills and understanding needed to use the database effectively and ensure compliance with EU regulations.
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].
- Regulatory Affairs Managers
- Quality Management Professionals
- Manufacturers, Authorized Representatives, Importers, Distributors, Sponsors
- Consultants and Specialists in Medical Technology
- Current legal and normative foundations
- MDR
- MDCG Guidance Documents
- BMG Publications
- EUDAMED's role in MDR/IVDR compliance
- Structure of EUDAMED
- Modules of the database and their linking
- Basics and definitions "What is UDI?"
- Regulatory requirements for UDI, implementation
- Overview of EUDAMED's functional specifications
- Data exchange and monitoring
- Rules of access to EUDAMED Definition, identification and handling of legacy devices
- Maintenance of data in EUDAMED
- Integration into the QM system
- Schedule and deadlines
Within the framework of the regulatory requirements of MDR (EU) 2017/745 and IVDR (EU) 2017/746, the European Commission is advancing the development of the European Medical Device Database—EUDAMED. This database plays a critical role in monitoring the safety and performance of medical devices, while also serving as a source of information for distributors, users, and patients.
EUDAMED aims to achieve its objectives through centralized, Europe-wide registration of medical devices, as well as their manufacturers, authorized representatives, and importers. It enhances transparency by documenting certificates issued by Notified Bodies and recording incidents related to CE-marked medical and in vitro diagnostic (IVD) devices. Portions of the database will be publicly accessible, ensuring that all stakeholders are well-informed.
The coordination of activities and communication between European authorities and the European Commission marks a significant step toward harmonized data management across the EU single market. To support market surveillance and product traceability, each medical device must be assigned a machine-readable code known as the Unique Device Identifier (UDI). This UDI is essential for recording and tracking devices within the EUDAMED system.
Given the complexity and importance of EUDAMED, it is crucial for manufacturers and other stakeholders to engage with the system through qualified training. Such training provides clarity on the types of data that must be entered, the sequence in which they should be submitted, and the deadlines that must be met. For instance, the first step involves applying for a Single Registration Number (SRN) via the module for economic operators. The SRN serves as the gateway to accessing and entering data into the database.
Now is the time to familiarize yourself with EUDAMED and gain the knowledge necessary to navigate its requirements confidently. Our specialized training course equips you with the skills and understanding needed to use the database effectively and ensure compliance with EU regulations.
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.
This training course addresses internationally valid standards. The contents correspond to the current status of the revision/harmonization.
Certificate of Attendance from the TÜV SÜD Academy
Included in the training course price is the eBook: "Medical Device Regulation (MDR)".
Basic understanding of the European regulatory framework is recommended.
Specialist lecturers from the TÜV SÜD Academy