Online EU IVDR 2017 746 Practitioner Training | Exemplar Global Certified

eLearning Modules

• 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
• Article 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
• MDCG

On completion of this Online EU IVDR Practitioner Training, successful Learners will have the knowledge needed to:

1. Explain the history, purpose, and structure of the EU IVDR, and the key terminology used throughout the regulation
2. Identify the types of the device covered by the EU IVDR, the rules for classification, and the routes to conformity
3. Describe the obligations of the economic operators and the PRRC
4. Describe the General Safety & Performance Requirements
5. Outline the requirements for Performance evaluation and Performance studies
6. Explain the Post Market Surveillance and Vigilance reporting requirements
7. Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements

Our Online EU IVDR Practitioner Training 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
• Authorized Representatives
• PRRCs

Before completing this course, each Learner should have the following prior knowledge: ISO 13485

•  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.

Medical Device Quality 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

EU IVDR Practitioner Training Assessment Methodology

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

EU IVDR Practitioner Training Certification

Exemplar Global certifies this Online Comprehensive EU IVDR 2017/746 Practitioner Training Course. Successful completion will entitle each Learner to receive a digital Certificate of Achievement.

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 full technology requirements

In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.