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About

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) course provides a comprehensive overview of the regulatory framework governing IVDs in the European Union. It covers key requirements including device classification, conformity assessment, and the role of notified bodies. The course explains performance evaluation, clinical evidence, and post-market surveillance obligations under IVDR. It highlights key changes from the IVDD, including increased scrutiny, transparency, and lifecycle compliance. Designed for industry professionals, it supports practical implementation and ensures regulatory readiness for EU market access.

Course Syllabus

  1. Practice Insight: Why the Transition from IVDD to IVDR Matters
  2. IVDD vs. IVDR: A Fundamental Legislative Shift
  3. Legislative Rationale: Why the IVDR Was Necessary
  4. Uniform Application Across the European Economic Area
  5. Regulation (EU) 2024/1860: The Extended Transition Framework
  6. Extended Transition Gantt Chart: Classes A–D (2022–2029)
  7. Practice Insight: Operationalising the Extended Transition
  8. Transition Table: Class D and Class C Extended Deadlines
  9. Transition Table: Class B, Class A (Sterile & Non-Sterile)
  10. Transition Eligibility Flowchart: Am I Covered by the Extension?
  11. Conditions for Transition Extension: A Compliance Checklist
  12. Lesson 1 Summary: Key Takeaways

  1. What Makes a Product an IVD? The Three-Test Framework
  2. Article 2(2): The Statutory Definition of an IVD Medical Device
  3. Functional and Diagnostic Intent: The Six Use Cases
  4. Software as an IVD: Regulatory Treatment Under the IVDR
  5. Practice Insight: Scope Determination for Borderline Products
  6. Specimen Receptacles: A Distinct IVD Category
  7. IVD vs. General Laboratory Equipment: Drawing the Line
  8. IVD Scope Decision Tree: Is This Product an IVD Under the IVDR?
  9. Companion Diagnostics (CDx): Article 2(7) and Co-Regulation
  10. Companion Diagnostic Co-Development Timeline: Drug ↔ IVD Alignment
  11. Lesson 2 Summary: Defining the IVD — Key Takeaways
  12. Practice Insight: Managing Software IVD Compliance

  1. The IVDR Classification System: Architecture at a Glance
  2. The Core Principle: Indirect Harm and Risk-Based Classification
  3. The Indirect Harm Matrix: Individual vs. Public Health Risk
  4. The Four Risk Tiers: Classes A, B, C, and D
  5. Risk Tier Visual: The Four-Band Classification Pyramid
  6. Classification Rule 1: Transmissible Agents — Class D
  7. Practice Insight: Navigating Class D Classification Complexity
  8. Classification Rules 2 and 3: Blood Grouping and High-Impact Tests
  9. Classification Rules 4–7: Self-Testing, General IVD, Residual, and Controls
  10. Classification Decision Flowchart: Applying the Seven Rules
  11. Classification in Practice: Worked Examples
  12. The Classification Decision Process: A Regulatory Workflow
  13. Practice Insight: Classification Pitfalls and Regulatory Traps
  14. Lesson 3 Summary: Risk-Based Classification — Key Takeaways

  1. The IVD Supply Chain Ecosystem: Five-Actor Model
  2. Shared Accountability: The Economic Operator Ecosystem
  3. Manufacturer Obligations: Article 10 — A Deep Dive
  4. QMS Architecture: The Seven Pillars of Article 10(8)
  5. Practice Insight: Building an IVDR-Compliant QMS
  6. Non-EU Manufacturers: The Authorised Representative (Article 11)
  7. AR Mandate Due Diligence: What an AR Must Verify Before Accepting
  8. Importers: Article 13 Obligations
  9. Distributors: Article 14 Obligations
  10. The Person Responsible for Regulatory Compliance (PRRC) — Article 15
  11. The PRRC Independence Model: Accountability Without Interference
  12. Practice Insight: PRRC Appointment and Risk Management
  13. Economic Operator Interaction: A Regulatory Map
  14. Supply Chain Verification Flowchart: From Import to End User
  15. The Health Institution Exemption: Article 5(5)
  16. Article 5(5) Decision Tree: Does the LDT Exemption Apply?
  17. Declaration of Conformity and CE Marking — Article 17 & 18
  18. CE Mark Anatomy: What Every Component Signifies
  19. Conformity Assessment Pathways: Class A to Class D
  20. Lesson 4 Summary: Economic Operators — Key Takeaways
  21. Technical Documentation: Annex II & III Structure at a Glance
  22. IVDR and MDR Interplay: Navigating Dual-Scope Products
  23. IVDR Compliance Roadmap: A 24-Month Action Plan
  24. Part 1 Key Regulatory Milestones at a Glance
  25. Key MDCG Guidance Documents for Part 1 Topics

  1. Regulatory Milestone: EUDAMED — Timeline & Mandatory Status
  2. EUDAMED's Six Modules: Architecture and Mandatory Functions
  3. EUDAMED Architecture: Six Modules Interconnected
  4. Single Registration Number (SRN): Purpose and Requirements
  5. EUDAMED Registration Workflow: From First Access to SRN
  6. EUDAMED Registration: Actor Roles and Device Data Entry
  7. EUDAMED Registration Timelines by Actor and Module
  8. Lesson 5 Summary: EUDAMED — Key Takeaways

  1. Regulatory Milestone: UDI — Architecture and Legal Basis
  2. UDI Architecture: Basic UDI-DI, UDI-DI, and UDI-PI
  3. UDI System Architecture: Three-Tier Hierarchy
  4. UDI Labelling Requirements: HRI and AIDC Formats
  5. IVD Label Anatomy: IVDR-Mandated Label Elements
  6. UDI Staggered Implementation Schedule by Device Class
  7. UDI Implementation Timeline by Device Class
  8. Lesson 6 Summary — Unique Device Identification

  1. Conformity Assessment — The Core Obligation
  2. Conformity Assessment Pathway Decision Flowchart
  3. Class A — Self-Certification Pathway
  4. Classes B, C and D — Notified Body Involvement
  5. EU Reference Laboratories (EURLs) and Expert Panels
  6. EURL Consultation Process — Timeline & Flow
  7. Lesson 7 Summary — Conformity Assessment Pathways

  1. Clinical Evidence — The IVDR Framework
  2. Three Pillars of IVDR Clinical Evidence
  3. Clinical Evidence Hierarchy — From Weakest to Strongest
  4. Performance Evaluation Plan (PEP) — Structure and Contents
  5. PEP Document Structure — Section Map
  6. Clinical Performance Studies — Key Requirements
  7. Post-Market Performance Follow-Up (PMPF)
  8. Legacy IVD Devices — The Clinical Evidence Gap
  9. Lesson 8 Summary — Clinical Evidence & Performance Evaluation

  1. Post-Market Surveillance — The IVDR Framework
  2. Post-Market Surveillance Continuous Improvement Cycle
  3. Vigilance — Serious Incident Reporting
  4. Vigilance Reporting Timeline — From Incident to Resolution
  5. Field Safety Corrective Actions (FSCAs)
  6. Closing the Loop — PMS Findings Mapped to GSPR (Annex I)
  7. Lesson 9 Summary — Post-Market Surveillance & Vigilance

  1. IVDR Key Regulatory Milestones — 2022 to 2030
  2. IVDR Compliance Quick Reference — Key Obligations by Class
  3. Top 10 IVDR Compliance Actions Before Market Placement
  4. Course Wrap-Up — IVDR Masterclass Part 2
  5. EUDAMED — Who Must Register and When
  6. EUDAMED Data Quality — Accuracy Obligations
  7. UDI Carriers — Choosing Between GS1 and HIBCC
  8. UDI Exceptions — Custom-Made and Investigational IVDs
  9. The IVDR Notified Body Landscape — Capacity Constraints
  10. Top Reasons for NB Assessment Delays and Rejections
  11. Scientific Validity — Conducting a Systematic Literature Review
  12. Clinical Performance Statistics — 2×2 Contingency Table Explained
  13. PMPF Data Sources — Methods and Frequency
  14. PMS Monitoring Dashboard — Key Performance Indicators
  15. Field Safety Notice (FSN) — Mandatory Content
  16. PSUR Structure — Section-by-Section Guide
  17. Authorised Representative — Responsibilities in Practice
  18. Importers and Distributors — New IVDR Obligations
  19. Is This a Serious Incident? — Decision Flowchart
  20. IVDR vs. IVDD — Key Regulatory Changes at a Glance
  21. Transitional Provisions — Understanding the Deadlines
  22. Summary of Safety and Performance (SSP) — Annex III
  23. IVDR Compliance — Realistic Cost Planning
  24. IVDR Key Definitions — Article 2 Quick Reference
  25. Staying Current — IVDR Regulatory Intelligence Sources

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Frequently Asked Questions

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) course provides a comprehensive foundation for understanding the regulatory framework governing IVDs in the European Union. It covers the entire product lifecycle, including device classification, conformity assessment procedures, and the role of notified bodies and expert panels. Key focus areas include performance evaluation (scientific validity, analytical and clinical performance), post-market surveillance, and post-market performance follow-up (PMPF). The course emphasizes technical documentation, Unique Device Identification (UDI), and EUDAMED requirements to ensure transparency and compliance. Aligned with current EU regulatory expectations, it equips professionals with practical knowledge to achieve and maintain IVDR compliance and market access.

  • Overview of EU IVDR (2017/746) regulatory framework for in vitro diagnostic medical devices
  • Device classification rules and conformity assessment pathways
  • Role and responsibilities of notified bodies and expert panels
  • Performance evaluation: scientific validity, analytical and clinical performance
  • Post-market surveillance and post-market performance follow-up (PMPF)
  • Technical documentation and compliance requirements
  • Unique Device Identification (UDI) and EUDAMED database requirements
  • Key differences between IVDD and IVDR and their impact on compliance

This course is ideal for professionals involved in the development, regulation, and compliance of in vitro diagnostic medical devices, including:

  • Regulatory Affairs and Clinical Affairs professionals
  • Quality Assurance and compliance teams
  • Professionals working with notified bodies or consulting services
  • CRO professionals and clinical project managers
  • Anyone seeking to understand EU IVDR (2017/746) requirements for market access
No prior IVDR experience is required, but a basic understanding of medical devices or regulatory frameworks is beneficial.

  • Comprehensive coverage of EU IVDR (2017/746) requirements for IVD compliance
  • Up-to-date insights on regulatory expectations, including notified body and EUDAMED requirements
  • Practical guidance on performance evaluation and post-market surveillance
  • Clear understanding of key differences between IVDD and IVDR
  • Supports regulatory readiness for EU market access and inspections
  • Certificate issued upon successful completion