EU MDR Training for Practitioners
EU MDR Training that takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.
Key Course Information
What you need to know?
Our industry-leading Online Training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Available Formats:
eLearning
Customized Learning
Learning Objectives
On completion of this training, successful Learners will have the knowledge needed to:
- Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
- Identify the types of devices covered by the EU MDR and the rules for classifying these devices
- Describe the obligations of the economic operators and the PRRC
- Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
- Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
- Explain the Unique Device Identifier requirements and the relationship with EUDAMED
Frequently Asked Questions
Reviews & Ratings
4.6
Average Rating
280 global ratings
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I thoroughly enjoyed the course. I already knew some of the content but found the new knowledge items very informative and well presented. I thought the course was well structured, clear and easy to follow. I would recommend this course to others.
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This course really helped improve my understanding of EU MDR.
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I found this course to be very informative and my understanding on EU MDR has greatly increased upon completion. This course would especially benefit someone who in working in the industry with little knowledge of EU MDR.
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Very well laid out Very comprehensive details Good resource references Nice mix of MCQs throughout
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Once again this was a great experience of leaning with Comply Guru.
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The training supplied was very well prepared and summarized. It was a well organized training.
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This very well-structured training.
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Excellent self-paced course that supports strong engagement from the learner - well worth my time completing this as I had to put in the effort in order to pass the exams.
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I thought the course was a good introduction to MDR - sections were clearly explained and reference material was provided. Lots of self-evaluation questions throughout and the ability to go back to review sections. I was able to complete in my own-time.
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very much useful and informative