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Advanced EU IVDR Practitioner Training (40hr) is for Quality & Regulatory Professionals who want comprehensive training on the European In Vitro Diagnostic Regulation (EU IVDR 2017/746).
Our blended learning course is a hybrid approach where you first complete 24hrs of eLearning modules on the underlying theory that better prepares you in advance of attending 2-days of Live Classes with an Instructor where Learners will work with case studies & scenarios that help deepen the understanding of the requirements in a real life context.
Course Overview
Advanced EU IVDR Practitioner
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
Introduction to the EU IVDR
- Purpose of the EU IVDR
- Structure of EU IVDR
- Key Terminology
- EU IVDR v IVDD – Key Changes
- EU IVDR Timelines for Transition
Medical Devices covered by the EU IVDR
- What is an in vitro medical device?
- Intended Purpose
- Devices in scope
- Devices out of scope
- Relationship with other Directives
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 17-21
Device Classification
- Principles of Classification
- Implementing Rules
- Continuous Use
- Classification Rules
- General Requirements for All Risk Classes
- Classification & Intended Use
Routes to Conformity
- 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
GSPR and Risk Management
- Chapter I General Requirements
- Risk Management
- Chapter II Design & Manufacture
- Chapter III Device Information
Clinical Evidence, Performance Evaluation & Performance Studies
- Performance Evaluation Introduction
- Clinical Evidence
- Annex XIII Part A – Scientific Validity
- Analytical and Clinical Performance
- Clinical Performance Studies
- Post Market Phase
- Performance Evaluation Report
Post Market Surveillance and Vigilance
- Chapter VII Post Market Surveillance
- Vigilance Terminology & Reporting
- Trend Reporting
- Article 89
- Additional Considerations
- IVD Medical Device Documentation
Technical Documentation, UDI and EUDAMED
- Annex II & III: Technical Documentation
- UDI Requirements & Timelines
- EUDAMED
- MDCG Guidance Documents
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
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 the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for (applies to blended format only)
- Fully attend the Live Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
- Complete a 1.5hr Final Examination* that is remotely invigilated (Live Proctored). Each Learner must obtain 70% or higher in the Final Examination which is completed securely online (under strict examination conditions).
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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