The In Vitro Diagnostic Regulation (IVDR), is a comprehensive set of European Union (EU) rules that govern the production, sale, and distribution of in vitro diagnostic devices. These devices play a crucial role in analyzing human samples, like blood or tissue, outside the body, providing essential data for medical diagnoses and treatment planning. This short course will focus on how the IVDR prioritizes safety, effectiveness, and the highest standards of public health within the EU.
On-demand - training that’s even more flexible
BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.
How will I benefit?
This course will help you:
- Understand the regulatory framework for In Vitro Diagnostic Devices in Europe
- Recognize the commercial advantages of obtaining the CE Mark as evidence of conformity with the IVD Regulation
- Identify actionable steps you can take to ensure compliance with the IVD Regulation and how it can benefit you
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?
All staff
What will I learn?
Upon completion of this course, you will be able to:
- Explain how In Vitro Diagnostic Devices are regulated in Europe
- Describe the commercial benefits of the CE Mark demonstrating conformity with the IVD Regulation
- Suggest actions you can take to help with compliance to the IVD Regulation
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.
