- Module 1: Introduction to the EU MDR
- History of MD scandals
- Purpose of EU MDR
- Structure of EU MDR
- Medical devices covered by EU MDR
- Key changes introduced by EU MDR
- Timelines for transition
- Module 2: Placing 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
- Brief overview of Classification, Conformity assessment, EU declaration of conformity and CE Marking
Our Free EU MDR 2017 745 Training ( Essentials Training ) is aimed at anyone working in the medical device industry sector who is looking to understand the basic essentials of the European Medical Device Regulation (EU MDR 2017 745). If you are not 100% sure or would like to refresh your knowledge, then this course is most definitely for you!
On completion, successful Learners will have the knowledge needed to:
Who should attend?
- Anyone working in the Medical Device Industry
- Quality assurance professionals
- Quality Engineers
- Research and Design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
In order to successfully complete FREE Online EU MDR 2017 745 Essentials eLearning course, each Learner will need to:
- Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
Upon registering for this course, each Learner will have 30-days of eLearning access to complete the course.
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Click here to read the full technology requirements.
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