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In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 Course & Certification
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About
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is a comprehensive program designed to help professionals understand the European regulatory framework governing in vitro diagnostic medical devices. The course provides practical knowledge of IVDR requirements, device classification, conformity assessment, clinical evidence, post-market surveillance, and the responsibilities of manufacturers and other economic operators throughout the product lifecycle.
This In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 Course & Certification provides structured training on IVDR compliance, EUDAMED, UDI requirements, performance evaluation, vigilance obligations, and regulatory pathways for placing IVD devices on the European market. Upon completion, learners receive certification demonstrating competency in IVDR requirements and regulatory compliance for in vitro diagnostic medical devices.
Who Should Enrol?
- Regulatory Affairs, Quality Assurance, and Compliance Professionals working with IVD medical devices.
- IVD Manufacturers, Product Development Teams, and Quality Management Personnel.
- Authorized Representatives, Importers, Distributors, and Economic Operators involved in the European IVD market.
- Clinical Affairs, Performance Evaluation, and Post-Market Surveillance Professionals.
- Entry-level professionals and consultants seeking IVDR certification and expertise in European IVD regulatory compliance.
What you will learn
Understand the structure of IVDR (EU) 2017/746, transitional provisions, IVD definitions, and risk-based classification requirements.
Learn the responsibilities of manufacturers, authorized representatives, importers, distributors, and other economic operators within the IVD supply chain.
Develop expertise in EUDAMED, UDI implementation, conformity assessment routes, and regulatory approval pathways for IVD devices.
Gain knowledge of performance evaluation, clinical evidence requirements, post-market surveillance, vigilance reporting, and lifecycle compliance obligations.
Course Syllabus
- Practice Insight: Why the Transition from IVDD to IVDR Matters
- IVDD vs. IVDR: A Fundamental Legislative Shift
- Legislative Rationale: Why the IVDR Was Necessary
- Uniform Application Across the European Economic Area
- Regulation (EU) 2024/1860: The Extended Transition Framework
- Extended Transition Gantt Chart: Classes A–D (2022–2029)
- Practice Insight: Operationalising the Extended Transition
- Transition Table: Class D and Class C Extended Deadlines
- Transition Table: Class B, Class A (Sterile & Non-Sterile)
- Transition Eligibility Flowchart: Am I Covered by the Extension?
- Conditions for Transition Extension: A Compliance Checklist
- Lesson 1 Summary: Key Takeaways
- What Makes a Product an IVD? The Three-Test Framework
- Article 2(2): The Statutory Definition of an IVD Medical Device
- Functional and Diagnostic Intent: The Six Use Cases
- Software as an IVD: Regulatory Treatment Under the IVDR
- Practice Insight: Scope Determination for Borderline Products
- Specimen Receptacles: A Distinct IVD Category
- IVD vs. General Laboratory Equipment: Drawing the Line
- IVD Scope Decision Tree: Is This Product an IVD Under the IVDR?
- Companion Diagnostics (CDx): Article 2(7) and Co-Regulation
- Companion Diagnostic Co-Development Timeline: Drug ↔ IVD Alignment
- Lesson 2 Summary: Defining the IVD — Key Takeaways
- Practice Insight: Managing Software IVD Compliance
- The IVDR Classification System: Architecture at a Glance
- The Core Principle: Indirect Harm and Risk-Based Classification
- The Indirect Harm Matrix: Individual vs. Public Health Risk
- The Four Risk Tiers: Classes A, B, C, and D
- Risk Tier Visual: The Four-Band Classification Pyramid
- Classification Rule 1: Transmissible Agents — Class D
- Practice Insight: Navigating Class D Classification Complexity
- Classification Rules 2 and 3: Blood Grouping and High-Impact Tests
- Classification Rules 4–7: Self-Testing, General IVD, Residual, and Controls
- Classification Decision Flowchart: Applying the Seven Rules
- Classification in Practice: Worked Examples
- The Classification Decision Process: A Regulatory Workflow
- Practice Insight: Classification Pitfalls and Regulatory Traps
- Lesson 3 Summary: Risk-Based Classification — Key Takeaways
- The IVD Supply Chain Ecosystem: Five-Actor Model
- Shared Accountability: The Economic Operator Ecosystem
- Manufacturer Obligations: Article 10 — A Deep Dive
- QMS Architecture: The Seven Pillars of Article 10(8)
- Practice Insight: Building an IVDR-Compliant QMS
- Non-EU Manufacturers: The Authorised Representative (Article 11)
- AR Mandate Due Diligence: What an AR Must Verify Before Accepting
- Importers: Article 13 Obligations
- Distributors: Article 14 Obligations
- The Person Responsible for Regulatory Compliance (PRRC) — Article 15
- The PRRC Independence Model: Accountability Without Interference
- Practice Insight: PRRC Appointment and Risk Management
- Economic Operator Interaction: A Regulatory Map
- Supply Chain Verification Flowchart: From Import to End User
- The Health Institution Exemption: Article 5(5)
- Article 5(5) Decision Tree: Does the LDT Exemption Apply?
- Declaration of Conformity and CE Marking — Article 17 & 18
- CE Mark Anatomy: What Every Component Signifies
- Conformity Assessment Pathways: Class A to Class D
- Lesson 4 Summary: Economic Operators — Key Takeaways
- Technical Documentation: Annex II & III Structure at a Glance
- IVDR and MDR Interplay: Navigating Dual-Scope Products
- IVDR Compliance Roadmap: A 24-Month Action Plan
- Part 1 Key Regulatory Milestones at a Glance
- Key MDCG Guidance Documents for Part 1 Topics
- Regulatory Milestone: EUDAMED — Timeline & Mandatory Status
- EUDAMED's Six Modules: Architecture and Mandatory Functions
- EUDAMED Architecture: Six Modules Interconnected
- Single Registration Number (SRN): Purpose and Requirements
- EUDAMED Registration Workflow: From First Access to SRN
- EUDAMED Registration: Actor Roles and Device Data Entry
- EUDAMED Registration Timelines by Actor and Module
- Lesson 5 Summary: EUDAMED — Key Takeaways
- Regulatory Milestone: UDI — Architecture and Legal Basis
- UDI Architecture: Basic UDI-DI, UDI-DI, and UDI-PI
- UDI System Architecture: Three-Tier Hierarchy
- UDI Labelling Requirements: HRI and AIDC Formats
- IVD Label Anatomy: IVDR-Mandated Label Elements
- UDI Staggered Implementation Schedule by Device Class
- UDI Implementation Timeline by Device Class
- Lesson 6 Summary — Unique Device Identification
- Conformity Assessment — The Core Obligation
- Conformity Assessment Pathway Decision Flowchart
- Class A — Self-Certification Pathway
- Classes B, C and D — Notified Body Involvement
- EU Reference Laboratories (EURLs) and Expert Panels
- EURL Consultation Process — Timeline & Flow
- Lesson 7 Summary — Conformity Assessment Pathways
- Clinical Evidence — The IVDR Framework
- Three Pillars of IVDR Clinical Evidence
- Clinical Evidence Hierarchy — From Weakest to Strongest
- Performance Evaluation Plan (PEP) — Structure and Contents
- PEP Document Structure — Section Map
- Clinical Performance Studies — Key Requirements
- Post-Market Performance Follow-Up (PMPF)
- Legacy IVD Devices — The Clinical Evidence Gap
- Lesson 8 Summary — Clinical Evidence & Performance Evaluation
- Post-Market Surveillance — The IVDR Framework
- Post-Market Surveillance Continuous Improvement Cycle
- Vigilance — Serious Incident Reporting
- Vigilance Reporting Timeline — From Incident to Resolution
- Field Safety Corrective Actions (FSCAs)
- Closing the Loop — PMS Findings Mapped to GSPR (Annex I)
- Lesson 9 Summary — Post-Market Surveillance & Vigilance
- IVDR Key Regulatory Milestones — 2022 to 2030
- IVDR Compliance Quick Reference — Key Obligations by Class
- Top 10 IVDR Compliance Actions Before Market Placement
- Course Wrap-Up — IVDR Masterclass Part 2
- EUDAMED — Who Must Register and When
- EUDAMED Data Quality — Accuracy Obligations
- UDI Carriers — Choosing Between GS1 and HIBCC
- UDI Exceptions — Custom-Made and Investigational IVDs
- The IVDR Notified Body Landscape — Capacity Constraints
- Top Reasons for NB Assessment Delays and Rejections
- Scientific Validity — Conducting a Systematic Literature Review
- Clinical Performance Statistics — 2×2 Contingency Table Explained
- PMPF Data Sources — Methods and Frequency
- PMS Monitoring Dashboard — Key Performance Indicators
- Field Safety Notice (FSN) — Mandatory Content
- PSUR Structure — Section-by-Section Guide
- Authorised Representative — Responsibilities in Practice
- Importers and Distributors — New IVDR Obligations
- Is This a Serious Incident? — Decision Flowchart
- IVDR vs. IVDD — Key Regulatory Changes at a Glance
- Transitional Provisions — Understanding the Deadlines
- Summary of Safety and Performance (SSP) — Annex III
- IVDR Compliance — Realistic Cost Planning
- IVDR Key Definitions — Article 2 Quick Reference
- Staying Current — IVDR Regulatory Intelligence Sources
- 📘 Bonus: In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) eBook (Free with purchase)
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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
- 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
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