Course Area
Availability
Available for 365 days after enrollment
Approximate Course Run Time
1 hour
Continuing Education Units
0.1
Course Fee
USD $150.00
E-learning content is available on demand
Course Details
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.
On-demand - training that’s even more flexible
This short course aims to give you a better understanding of the Risk Classification requirements as per the EU MDR (2017/745). We discuss why there is a need to classify, the importance of stating the intended purpose and how this plays a role in applying the correct conformity assessment procedures.
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
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’s included?
- This is an online, interactive on-demand course.
- The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.
- Duration 1 hour
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Modules
- Risk Classification - Module 1
- Risk Classification - Module 2
