Global
Ireland
Finland
United Kingdom
United StatesEU MDR Requirements Training for Practitioners working with the European Medical Device Regulation (2017/745)
EU MDR Requirements 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.
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. 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.
This course is an internationally accredited credential offering global recognition. CQI and IRCA certify this course (No. 2378) and the Regulatory Affairs Professionals Society recognize this course where members will be eligible for RAPS credits (12).
Overview of our EU MDR Requirements Training
What's covered on our EU MDR Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- 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
- Relationship with other Directives
- Legacy Devices
Case Study! Medical Device Scope
Case Study! Scope and Legacy Devices
- 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
Case Study! Qualifications of the PRRC
Case Study! Change of Authorized Representative
Case Study! Declaration of Conformity
Case Study! A PRRC under Pressure
- 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
Case Study! Device Classification
- 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
Case Study! Route to Conformity
- Chapter I General Requirements
- Risk Management
- Chapter II Design & Manufacture
- Chapter III Device Information
Case Study! GSPRs 1 – 8
- 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
Case Study! Excerpt of a CER for Review
- Chapter VII Post Market Surveillance
- Vigilance Terminology & Reporting
- Trend Reporting
- Article 89
- Additional Considerations
- Medical Device Documentation
Case Study! Periodic Safety Update Report
- Annex II & III: Technical Documentation
- UDI Requirements & Timelines
- EUDAMED
- MDCG Guidance Documents
Michelle Keane
Eoin Philip Kelly
On completion of this course, successful Learners will have the practical knowledge and be able 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
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).
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).
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)
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.
Need Corporate, In-House or Customized Training?
Comply Guru offers corporate, in-house and customized training solutions for your organization’s specific needs.
Speak with an experienced member of our team today to learn how we can help.
Frequently Asked Questions
Not all eLearning is the same
Training Transformed with Comply Guru
What Our Learners Are Saying
4.6
Average Rating
386 global ratings
-
It was very clear and helpful. It provides a good basis.
-
Great course with a good mix of content, and a wealth of resources to review. I do think some of the questions could have been worded better, but on the whole I thought the course was excellent.
-
Extensive overview of the EU MDR, offering detailed explanations and updated advice for anyone working with it. I particularly enjoyed both the vast resources that were made available and the case studies. Engagement 4 out of 5, Quality 5 out of 5, Goal achieved 6 out of 5.
-
I really enjoyed the course. It was thorough, well structured, and clear. The knowledge checks were very helpful and made the learning more effective. It helped me organize and consolidate my understanding of MDR requirements. Highly recommended.
-
Informative and clearly structured.
Related Training Courses
