Module 0: Course Introduction

• Accessibility & Player Features
• Course Objectives
• Course Description
• Module Structure
• Assessment
• Meet Our Partner and Expert
• Learner Support
• Available Resources

Module 1: Introduction to the IVDR

• Purpose of the IVDR
• Structure of IVDR
• Key Terminology
• IVDR v IVDD – Key Changes
• IVDR Timelines for transition

Module 2: Devices covered by 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 5: 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
• MDCG