In Vitro Diagnostic Medical Devices Regulation (IVDR)

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Adding value with our service portfolio

ABOUT THE IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION (IVDR) E-LEARNING COURSE

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.

Duration of the training: 105 minutes
Login access duration: 365 days
Learning mode: Self-Paced (LMS)
Language: English

WHAT WILL YOU LEARN FROM THE IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION (IVDR) E-LEARNING COURSE?

This e-learning course 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

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 postmarket surveillance under IVDR

WHAT IS THE COURSE METHODOLOGY?

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.

WHO SHOULD TAKE THE COURSE?

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

WHO IS THE COURSE ADVISOR?

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.

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