European Database on Medical Devices (EUDAMED)
By the end of this training, the learners will be able to:
- Explain European Database on Medical Devices (EUDAMED)
- Define the purpose of the EUDAMED
- Determine the key principles of EUDAMED
- Outline the structure of EUDAMED
- Recognize the current condition of EUDAMED implementation
- Discuss the EUDAMED readiness and timeline
Who Should Attend?
All medical device stakeholders.
Course Agenda
- Definitions
- Key principles of European Medical Device Nomenclature (EMDN)
- Actor's Registration
- Actor's Registration - EUDAMED Registered Users
- UDI/Devices Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-market Surveillance
- Market Surveillance
- EUDAMED Entry into Force
Course Description
EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
By completing this training module, participants will gain a deeper understanding not only of the concept of EUDAMED, but also of the purpose, structure and key principles. In addition, the course will also highlight on the current condition of the EUDAMED implementation.
Benefits
The MDR's EUDAMED implementation has been postponed; the revised go-live date is anticipated in Q2 2024. In Q4 2024, actors' registration, clinical investigations, performance studies, vigilance, and post-market surveillance will all require mandatory usage of the database. In Q2 2026, the unique device identification (UDI) and device registration will become mandatory.
This training course provides a foundational on the topic.
Self-paced: access 24/7 to the course during 12 months at your own rhythm.
Methodology
This is a self-paced eLearning training. To ensure that the course runs smoothly, a standard PC with a web browser and a DSL internet connection are required. In order to be able to provide you with access to the e-learning course content, a personal e-mail address is required.
Learning Assessments
Successful completion provides learners with a dated, traceable and downloadable certificate of attendance by the TÜV SÜD Academy for the digital course: European Database on Medical Devices (EUDAMED).
Prerequisites
Certification requirements: Learners must complete at least 80% of the training module and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of attendance will be immediately accessible in PDF format after satisfying the requirements.
FAQs
System requirements
Supported browsers include:
- Chrome
- Safari
- Edge
- Firefox
Additional requirements include:
- A high-speed internet connection will provide best results.
- An email address is required to register for courses.
- Microsoft Media Player or equivalent is needed to play audio and video files.
What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included, and this will vary by course.
Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).
Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.
Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.
What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.
If you have questions, or require assistance, you may reach us at [email protected]
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