- Module 1: 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
- Module 2: Devices covered by EU IVDR
- What is an in vitro medical device?
- Devices in scope
- Devices out of scope
- Relationship with machinery and atomic energy directive
- Module 3: Placing a Device on the Market
- Chapter II Terminology
- Articles 5-9
- Economic Operator & PRRC Responsibilities
- Articles 16-21
- Module 4: Device Classification
- Implementing Rules
- Classification Rules 1-7
- Module 5: Routes to Conformity
- Conformity assessment annexes IX, X, XI
- Article 48 Devices categories and groups
- Special device conformity
- Derogation from conformity assessment
- Notified Bodies
- Module 6: GSPR & Risk Management
- Overview of Annex I
- Chapter I General Requirements
- Risk Management (ISO 14971)
- Chapter II Performance, design & manufacture
- Chapter III Device information
- Module 7: Performance Evaluation and Performance Studies
- Article 56 & 57
- Performance study articles
- Annex XIII Part A
- Annex XIII Part B
- Annex XIV
- Summary of safety and performance
- Module 8: Post Market Surveillance & Vigilance
- Post market surveillance articles 78-81
- Vigilance terminology
- Vigilance reporting
- Trend reporting
- Analysis of serious incidents and FSCA
- Data analysis
- Module 9: Technical Documentation, UDI and EUDAMED
- Annex II & III, UDI terminology
- Annex VI, UDI timelines
- EUDAMED databases
- EUDAMED timelines
On completion, successful Learners will have the knowledge needed to:
- 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
Who Should Attend?
Online EU IVDR 2017 746 Training course is aimed at anyone working in the in-vitro diagnostic medical device sector who is responsible for or involved in ensuring compliance to EU IVDR 2017 746 including but not limited to:
- Regulatory affairs
- Design and development
- Quality Management/Assurance
- Quality Engineers
- Internal Auditors
- Authorised Representatives
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)
Upon registering for this course, each Learner will have 90-days of eLearning access to complete the course, including final assessments.
Recommended Prior Learning
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 2016 Foundation (FD132) training course or equivalent.
Medical Device Management Systems
Knowledge of the following quality management principles and concepts:
- 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
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.
Click here to read the full technology requirements.
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