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United StatesEU IVDR Requirements Training for Practitioners working with the European In Vitro Diagnostic Regulation (2017/746)
EU IVDR Requirements Training for Practitioners that takes you through the new European In Vitro Diagnostic Regulation (2017/746), 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.
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. The Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants and RAPS credits for members.
Overview of our EU IVDR Requirements Training
What's covered on our EU IVDR Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- Purpose of the EU IVDR
- Structure of EU IVDR
- Key Terminology
- EU IVDR v IVDD – Key Changes
- EU IVDR Timelines for Transition
- What is an in vitro medical device?
- Intended Purpose
- Devices in scope
- Devices out of scope
- Relationship with other Directives
- Overview of Chapter II
- Articles 5-9
- Articles 10-16
- Manufacturer Obligations
- Authorized Representative
- Importer & Distributor Obligations
- Person Responsible for Regulatory Compliance (PRRC)
- Articles 17-21
- Principles of Classification
- Implementing Rules
- Continuous Use
- Classification Rules
- General Requirements for All Risk Classes
- Classification & Intended Use
- Overview of Conformity Assessment
- Annex IX Overview including Chapters 1-3
- QMS: Additional MDR Requirements
- Annex X Type Examination
- Annex XI Production Quality Assurance
- Conformity Assessment of Device Class
- Special Device Conformity
- Derogation from Device Conformity
- Notified Bodies
- Chapter I General Requirements
- Risk Management
- Chapter II Design & Manufacture
- Chapter III Device Information
- Performance Evaluation Introduction
- Clinical Evidence
- Annex XIII Part A – Scientific Validity
- Analytical and Clinical Performance
- Clinical Performance Studies
- Post Market Phase
- Performance Evaluation Report
- Chapter VII Post Market Surveillance
- Vigilance Terminology & Reporting
- Trend Reporting
- Article 89
- Additional Considerations
- IVD Medical Device Documentation
- Annex II & III: Technical Documentation
- UDI Requirements & Timelines
- EUDAMED
- MDCG Guidance Documents
Michelle Keane
Eoin Philip Kelly
- Explain the history, purpose, and structure of the EU IVDR and the key terminology used throughout the regulation
- Identify the types of the device covered by the EU IVDR, the rules for classification, and the routes to conformity
- Describe the obligations of the economic operators and the PRRC
- Describe the General Safety & Performance Requirements
- Outline the requirements for Performance evaluation and Performance studies
- Explain the Post Market Surveillance and Vigilance reporting requirements
- Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements
This course is aimed at anyone working in the in-vitro diagnostic medical device sector who is responsible for or involved in ensuring compliance to the EU IVDR 2017/746 including but not limited to:
- Regulatory affairs
- Design and development
- Quality Management/Assurance
- Quality Engineers
- Internal Auditors
- Authorized Representatives
- PRRCs
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).
Successful completion will entitle each Learner to receive a digital Certificate of Achievement.
Before completing this course, each Learner should have the following prior knowledge:
- Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485 Foundation (FD132) training course or equivalent.
- The relationship between ISO 13485 and the EU IVDR 2017 746
- Commonly used quality management terms and definitions within ISO 13485
- 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 all 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.
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79 global ratings
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The presenter was knowldegeable on the subject and gave very good tips and insights
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Excellent training
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The training provided was on point. The trainer has wide experiences in the industry especially in auditing, regulatory and training. The material for the training is good.
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My overall training experience with Comply Guru has been excellent. The content was clearly structured, easy to follow, and delivered in a way that made even complex regulatory topics feel manageable.
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The tests were challenging.
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