European Database on Medical Devices (EUDAMED)

E-Learning90 MinutesBeginnerSelf-paced / e-Learning

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

All medical device stakeholders.

1. What is the European Database on Medical Devices (EUDAMED)?
  • Definitions
2. Purpose of EUDAMED
  • Key principles of European Medical Device Nomenclature (EMDN)
3. Structure of EUDAMED
  • 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
4. Current condition of EUDAMED implementation
  • EUDAMED Entry into Force
The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).
EUDAMED aims to enhance transparency about medical devices, including better access to information for the public and healthcare professionals, and enhancing coordination among EU member states.
EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.

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.

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.

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Self-paced: access 24/7 to the course during 12 months at your own rhythm.

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.

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).

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.

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]

To learn more about TÜV SÜD, please click here.

Price (excl. TAX)
$ 75.00

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