On May 5, 2017, the EU IVD Medical Device Regulation (IVDR), was published in the Official Journal of the European Union. Published as Regulation (EU) 2017/746 it covers in vitro diagnostic medical devices, its requirements refer to the European Commission, as well as manufacturers, Notified Bodies and member state competent authorities. A five-year transition period for all economic operators involved in IVD medical devices in Europe began on May 25, 2017.
To help medical device manufacturers with the complexity of the new EU IVDR, we have developed an eLearning course, introducing the key changes and implications of the regulation. The course also covers how IVDR requirements will affect your organization.
Course Objectives
This eLearning course provides participants with an overview of the critical changes in relation to EU IVD Medical Device Regulation, along with implementation timescales and impact on the resources.
Target Audience
Our online training course is intended for, but not limited to, regulatory personnel, managers, CEOs, CFOs, IVD device industry employees and IVD device users who want to learn about the new regulation.
Course Content
This course covers the following topics:
- An overview of the new regulation
- The key changes you need to be aware of
- What the EU IVD Medical Device Regulation means in practice
- Where you can find further information
- A quiz to test your knowledge
Completion Criteria
Learners will be required to complete the entire course and gain a pass mark of 8/10 or more in the final assessment. Once your training is complete, learners will be able to download a certificate of completion. You will be granted 12 months’ access to this course, effective from the date of purchase.
To find out more about our EU IVD Medical Device Regulation eLearning course, or to book your training, contact us today.
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