46-43-22-0011

In Vitro Diagnostic Medical Devices Regulation (IVDR)

E-Learning105 MinutesBeginnerSelf-paced / e-Learning

In this e-Learning self-paced course, you will:

  • Learn to explain the In Vitro Diagnostic Medical Devices Regulation.
  • Gain awareness of the new IVDR on quality management system and requirements according to Article 10 (8).
  • Be able to define key terms with regard to IVDR.

There are three modules to this e-learning course, each containing various sub-modules:

  • Technical Documentation requirements.
  • Quality Management System requirements.
  • Understanding of traceability requirements and post-market surveillance under IVDR.

This is a foundation level course on In Vitro Diagnostic Medical Devices Regulation (IVDR). It covers basic information about the new regulation, classification of rules and procedure to carry out the assessment. The course is divided into three modules that details on Technical Documentation requirements under IVDR. Quality Management System requirements under IVDR and Understanding of traceability requirements and post-market surveillance under IVDR.

The Technical Documentation requirements under the IVDR module are created for building an understanding of regulations and technical documentation that play an important role in IVDR. Further the requirements of Quality Management System which emphasize on Article 10 (8) of EU MDR 2017/746, under the general obligation of manufacturers states that manufacturers must demonstrate performance, safety and possible risks/controls of products prior to availability within the European marketplace

You will leave this e-Learning course with the following key benefits:

  • Basic Awareness of the new regulation.
  • Explain In Vitro Diagnostic Medical Devices Regulation.
  • Discuss the impact of the new IVDR on the quality management system and requirements under Article10(8).
  • Describe some of the important terms such as market surveillance, unique device identification, and their traceability.

Online. Self-paced.

System requirements

Supported browsers include:

  • Chrome
  • Safari
  • Internet Explorer
  • Firefox

Additional requires 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.
  • Flash Player is used for content and interactive learning. If necessary download and install Flash Player to ensure proper operation of course content.

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.


If you are unable topurchase online please contact our team today at [email protected] or (978) 573-1997.

Price (excl. TAX)
$ 145.00

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