Online Introduction to the new EU MDR
Medical Device Regulation (MDR) Overview Course (EU) 2017/745
We have a
& study at your own pace
with tutor support when you need it
No additional fees
No membership or assessment fees
This fully online EU MDR training course provides an excellent foundation of the Medical Device Regulation 2017/745 for anyone working in the Medical Device Industry. This course provides you with full flexibility to learn at your own pace and in your own time.
In this course, you'll cover 2 units:
Unit 1: Introduction to the EU MDR
▪ History of MD Scandals
▪ Purpose of the EU MDR
▪ Structure of the EU MDR Definitions
▪ Medical Devices covered by the EU MDR
▪ Key Changes introduced by the EU MDR
▪ Timelines for Transition
Unit 2: Placing a Device on the Market
▪ Overview of Articles 10, 11, 13-15
▪ Role of the Manufacturer
▪ Authorised Representative
▪ Importer, Distributer and Person Responsible for Regulatory Compliance
▪ Overview of articles 5, 19 & 20
▪ Overview of Classification
▪ Conformity assessment
▪ EU declaration of conformity and CE Marking
For further details, download our course overview.
You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher.
Successful completion will entitle you to receive an EU MDR certificate of completion.
After the course is completed, you can still go back in during your access period to review the course content as many times as you like.
Working knowledge of medical device quality management systems (QMS) and risk management is recommended but not required.
This online EU MDR training course is suitable for anyone working in the medical device industry who is looking for an overview of the EU MDR and is suitable for beginners.
We have partnered with Comply Guru, an expert leader in online training to make our MDR course available as an eLearning course.
Enquire today and one of our team will send you more information about the course, answer any questions you may have and help you enrol.
"This is my second online course within two weeks. I was not very sure of online training at first but I can do it at my own pace and go back and review information when I need, which for me is very helpful and I can take notes at my own pace."
- Marie Ivers | May 20, 2020
"The overall training experience was very good the system is very user friendly and everything was very well explained."
- Mary Prunty | May 7, 2020
"I enjoyed the 2 modules. I found it very informative. It was a good overview of the MDR. The e-learning platform was easy to navigate."
- Michelle Reinecke-Quain | May 2, 2020
"Excellent video presentations. I liked the quizzes particularly the fact that the structure of the quizzes varied in nature. I also liked the fact that you could expand parts of the course this allows the learner to tailor the course to their own level of knowledge."
- Angela O'Sullivan | April 8, 2020