EU IVDR Training 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.
EU IVDR Training for Practitioners
Our online training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
On completion of this course, 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
A summary of learning topics within this course include:
- 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?
- Devices in scope
- Devices out of scope
- Relationship with Machinery and atomic energy directive
- Chapter II Terminology
- Articles 5-9
- Economic Operator & PRRC Responsibilities
- Articles 16-21
- Implementing Rules
- Classification Rules 1-7
- Conformity assessment annexes IX, X, XI
- Article 48 Devices categories and groups
- Special device conformity
- Derogation from conformity assessment
- Notified Bodies
- Overview of Annex I
- Chapter I General Requirements
- Risk Management (ISO 14971)
- Chapter II Performance, Design & Manufacture
- Chapter III Device information
- Articles 56 & 57
- Performance study articles
- Annex XIII Part A
- Annex XIII Part B
- Annex XIV
- Summary of safety and performance
- Post-market surveillance articles 78-81
- Vigilance terminology
- Vigilance reporting
- Trend reporting
- Analysis of serious incidents and FSCA
- Data analysis
- Annex II & III, UDI terminology
- Annex VI, UDI timelines
- EUDAMED databases
- EUDAMED timelines
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 EU IVDR including but not limited to:
- Regulatory affairs
- Design and development
- Quality Management/Assurance
- Quality Engineers
- Internal Auditors
- Authorized Representatives
Exemplar Global certifies our Comprehensive EU IVDR Training for Practitioners Course. 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) 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.
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About Our EU IVDR Training for Practitioners
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What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
44 global ratings
Comply Guru makes it easy to learn about new topics. I enjoy these courses.
I thought for an online course it was very well put together as a good learning experience. I specifically enjoyed the parts where there was a speaker, I thought this information was always quiet informative.
Overall good training.
Provided a good grounding on the IVDR and improved my overall understanding of requirements. provided links to use full resources.
A very professional and well constructed course, the team gave excellent feedback and support when needed. The content was detailed, but delivered in a way that was very manageable, and the self directed model allowed me to complete the course when I had free time from work and family commitments. I fully endorse and recommend this course for anyone looking to strengthen their understanding of the IVDR.
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