Advanced EU IVDR Practitioner Training

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