In Vitro Diagnostic Medical Devices Regulation (IVDR) E-learning Course

The course is divided into three modules that detail 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 emphasise 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.

In this In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course, we aims to:

• Provide basic awareness of the new regulation
• Explain In Vitro Diagnostic Medical Devices Regulation
• Discuss the impact of the new IDVR 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

• Technical Documentation requirements
• Quality Management System requirements
• Understanding of traceability requirements and postmarket surveillance under IVDR

This e-learning course is specially designed for:

• Manufacturers of medical devices
• Regulatory Affairs
• Design and Development
• Quality Management
• Quality Assurance personnel, clinical affairs specialists, students and professors

The course structure and content are developed by experts from TÜV SÜD’s Digital Academy Approval Board. Consisting of product specialists and technical experts, they have been working with organisations around the world to achieve business excellence.

This assures you that the course has been created with meticulous instruction, introducing you to diverse perspectives and best practices.

1. How do I enroll for the In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course?
To enroll, please click on "Buy now" and check out your cart.

2. What is included with the In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course?
You get access to our e-learning content along with the assessments that will help you understand the topics in depth. In the event of any technical difficulties, you can contact us for support.

3. Can I pause the In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course and log in to it anytime?
Yes. The In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course allows you to take a break and return to it within the defined access period.

4. Are there any tests in the middle of the In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course?
Yes, there are interactive quizzes throughout the In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course to gauge your understanding of the lectures.

5. Can I get a refund if I cancel my enrollment?
No, refund is not possible once the account is activated.

6. What happens if I don't finish the In Vitro Diagnostic Medical Devices Regulation (IVDR) e-learning course within the access period?
Access period may be adjusted for B2B customers depending on what was agreed in the contract. For B2C customers, access runs only for 30 days.

7. What is the methodology of the e-learning course?

• The course employs a variety of training tools such as digital learning, tests, and other interactive exercises to enhance delivery of theoretical knowledge. Easily accessible via your laptop, tablet and mobile phone, the course gives you the opportunity to log in and learn whenever, wherever.
• The cumulative duration of the programme is 105 minutes, after which you will be required to pass a quiz to receive your internationally recognised e-certificate with a unique ID.