European Medical Device Regulation (EU MDR 2017/745) Comprehensive Practitioner Training that takes you through the new EU MDR 2017/745, not just from an industry perspective, but also from a Notified Body perspective. This course has been specifically designed for Quality & Regulatory Professionals.
Key Course Information
What you need to know?
Our 20hr EU MDR Training for Practitioners eLearning course 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.
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
A summary of learning topics within this course include:
- History, Purpose & Structure of the EU MDR
- Key Terminology
- Key EU MDR changes
- EU MDR Timelines for Transition
- What is a device?
- Devices in & out of scope
- Non-Medical devices
- Overview of Chapter II
- Articles 5-9
- Economic Operator & PRRC Responsibilities
- Articles 16-24
- Overview of Annex VIII
- Class Types & Classification Rules
- Overview of Conformity Annexes
- Annexes IX, X & XI
- Custom Made Devices
- Notified Body Articles & Annexes
- Overview of Annex I
- Chapter I General Requirements
- Risk Management (ISO 14971)
- Chapter II Design & Manufacture
- Chapter III Device Information
- Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV
- Overview of PMS Articles 83-86
- Overview of Vigilance Articles 87-89
- Annex II and Annex III Technical documentation
- Unique Device Identification (Annex VI)
- UDI Timelines
- Overview of EUDAMED
Who Should Attend?
This course has been designed for those working in Quality Assurance and/or Regulatory Affairs who want to gain a better understanding of the EU Medical Device Regulation (EU MDR 2017/745), including:
- Quality Assurance Professionals
- Quality Engineers
- Research and Design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
Before completing this course, each Learner should have the following prior knowledge:
- A working knowledge of ISO 13485, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course
- The relationship between ISO 13485 and the EU MDR 2017/745
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
- A working knowledge of risk management principles related to the design of a medical device, through ISO 14971
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) within the 90-day course license
CQI & IRCA certify this course (No. 2378). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.
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. Read the full technology requirements here.
Frequently Asked Questions
Reviews & Ratings
280 global ratings
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.
This course really helped improve my understanding of EU MDR.
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.
Very well laid out Very comprehensive details Good resource references Nice mix of MCQs throughout
Once again this was a great experience of leaning with Comply Guru.
The training supplied was very well prepared and summarized. It was a well organized training.
This very well-structured training.
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.
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.
very much useful and informative