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
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's included?
On completion, you’ll be awarded an internationally recognized BSI training course certificate.
Prerequisites
There are no formal prerequisites for this course.
