Introduction to this course: 

This course covers EU MDR requirements and regulatory fundamentals for medical devices. Learn about CE marking, conformity assessment, and post-market obligations under EU MDR 2017/745 and IVDR 2017/746.

Who should attend: 

This course is designed for professionals involved in the EU medical device industry, particularly those in the development, and marketing of medical devices. The course is also suitable for anyone interested in understanding the medical device industry. 

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Recall key EU MDR regulations and their implications.

• Identify medical device classes in the EU

• Interpret CE marking requirements and conformity assessment procedures.

What will I gain: 

Participants will gain a comprehensive understanding of the EU regulatory environment, and an understanding of the EU classification of medical devices, as well as other key concepts.

Prerequisites: 

Participants should have a basic understanding of medical device development and regulatory processes. Familiarity with quality management systems and international standards is beneficial.

Additional information: 

Course duration: 00:22:56

Course code/version (effective date): L-146_B/v1.0 (20/09/2023)