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United StatesEU MDR Training for Practitioners 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. This course has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Course Overview
EU MDR Training for Practitioners
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
Introduction to the EU MDR
- History, Purpose & Structure of the EU MDR
- Key Terminology
- Key EU MDR changes
- EU MDR Timelines for Transition
Medical Devices covered by the EU MDR
- What is a device?
- Devices in & out of scope
- Relationship with other Directives
- Legacy Devices
Placing a Device on the Market
- Overview of Chapter II
- Articles 5-9
- Articles 10-16
- Manufacturer Obligations
- Authorized Representative
- Importer & Distributor Obligations
- Person Responsible for Regulatory Compliance (PRRC)
- Articles 17-20
- Articles 21-24
Device Classification
- Types of Risk Class
- Duration of Use
- Types of Body Contact
- Principles of Classification
- Continuous Use
- Classification Rules
- Non-Invasive Rules 1-4
- Invasive Rules 5-8
- Active Devices Rules 9-13
- Special Classification Rules
Routes to Conformity
- Overview of Conformity Assessment
- Annex IX Overview including Chapters 1-2
- QMS: Additional MDR Requirements
- Annex X Type Examination
- Annex XI Product Conformity Verification
- Conformity Assessment of Device Class
- Special Device Conformity
- Derogation from Device Conformity
- Notified Bodies
GSPR and Risk Management
- Chapter I General Requirements
- Risk Management
- Chapter II Design & Manufacture
- Chapter III Device Information
Clinical Evaluation
- Clinical Evaluation Introduction
- Article 61 Exemption and Update
- Annex XIV Part A: Clinical Evaluation and Part B: PMCF
- Summary of Safety & Clinical Performance (SSCP)
- Clinical Evidence for Legacy Devices
- Clinical Data Requirements
Post Market Surveillance and Vigilance
- Chapter VII Post Market Surveillance
- Vigilance Terminology & Reporting
- Trend Reporting
- Article 89
- Additional Considerations
- Medical Device Documentation
Technical Documentation, UDI and EUDAMED
- Annex II & III: Technical Documentation
- UDI Requirements & Timelines
- EUDAMED
- MDCG Guidance Documents
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
CQI & IRCA certify this course (No. 2378). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.
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
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.
Why Choose Comply Guru
About Our EU MDR Training for Practitioners
Learn about how our Multi-Accredited EU MDR Training for Practitioners is leading the industry for innovation through online learning
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.6
Average Rating
316 global ratings
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The exam times of 45 minutes was too short and add undue pressure.
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Very challenging, but also innovative approach. Knowledge checks are not all important information, in my opinion - it tests more the ability to memorize peculiarities than the core of the topic, but I understand that you might have liked it that way. All in all, I think it helped me develop basic knowledge and I would recommend it.
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Great interactive course.
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Excellent course
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The material was clearly presented, with the interactive setup ensuring engagement, resulting in one really taking in the material and gaining in-depth understanding of the MDR. Overall, a great course!
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