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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.

Course aim    

Overall, this awareness course will help you understand what the IVD Regulation is, why it’s important, and how you can help your organization comply with this Regulation.

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

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

Who should attend?

All staff

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.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI training course certificate.

Further information

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

Related training

Requirements of the In Vitro Diagnostic Regulation On-demand Training Course

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

Modules

• Awareness of the In Vitro Diagnostic Regulation (IVDR) On-demand Training Course