The European Medical Devices Regulation (MDR), was published in the Official Journal of the European Union on May 5, 2017. Published as Regulation (EU) 2017/745, it covers medical devices and active implantable medical devices. Its requirements refer to the European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. The new regulation is almost three times as long as and much stricter than the previous Medical Device Directive (MDD). The three-year transition period for all economic operators involved in medical devices in Europe began on May 25, 2017.
To help medical device manufacturers with the complexity of the new regulation standard, we have developed an eLearning course, introducing the key changes and implications of the regulation. The course also enables you to understand how MDR will affect your organization.
This course will provide participants with an overview of the critical changes in relation to EU Medical Devices Regulation, along with the implementation timescales and impact on the resources.
Our training course is intended for, but not limited to, regulatory personnel, managers, CEOs, CFOs, medical device industry employees and medical device users who want to learn about the new regulation.
This course covers the following topics:
- An overview of the new regulation
- The key changes you need to be aware of
- What EU MDR means in practice
- Where you can find further information
- A quiz to test your knowledge
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 Introduction to the EU Medical Devices Regulation eLearning course, or to book your place, contact us today.