The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.
Learn about the key requirements of risk classification under the MDR, gain a better understanding of the risk classification rules, the need to classify and why the intended purpose of a device is important.
How will I benefit?
This course will help you:
- Appreciate the risk classification requirements as per the MDR
- Gain an understanding of the risk classification rules with typical device examples
Please Note
- The course features interactive elements, knowledge checks, and comprehension tests. While we provide an estimated duration on the website, the actual completion time may vary based on your progress.
- You'll have access to this course lasting 90 days from activation, allowing you to revisit and review materials whenever and wherever it suits your schedule.
Who should attend?
Quality, Regulatory, Technical professionals working in the Medical Device industry
What will I learn?
By the end of the course you will be able to:
- Establish the requirements of Risk Classification as per the MDR Annex VIII
- Understand the medical device risk classification rules
- Appreciate the importance of the intended purpose driving the risk classification and selecting the appropriate conformity assessment procedure
What will I gain?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
How will I learn?
This is an online, interactive on-demand course.
Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection.
You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue.
During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned.
The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.
Benefits of On-Demand for the individual
Convenient - courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection
Learning pace - You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue
Information retention - During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned
High-quality materials - Developed by top subject matter experts, course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning
Enrollment and Access
- Once you've completed your registration and payment, you'll receive a system-generated activation email with password set up instructions.
- The course content can be accessed and reviewed multiple times within 90 days of receiving the activation email.
- For course-related questions or technical issues, please contact:
- Ms. Maggie Chiang: 02-26560333 ext. 139
- Ms. Winnie Tsai: 02-26560333 ext. 145
, or email us at Maggie.chiang@bsigroup.com / Winnie.tsai@bsigroup.com
- BSI reserves the right to make final interpretations of course-related policies.
- To learn more about our On-Demand Courses, please visit our website.
