Program Overview
This corporate training program provides a comprehensive introduction to the EU In Vitro Diagnostic Regulation (IVDR 2017/746), equipping professionals with practical knowledge to manage compliance under the new framework. Delivered by an industry expert with over 25 years of experience, the course blends conceptual clarity, situational awareness, real-world case studies, and interactive exercises. Participants will explore the transition from IVDD to IVDR, risk-based device classification, performance evaluation requirements, notified body challenges, and post-market obligations. The program emphasizes deep-domain regulatory insights while providing actionable strategies to navigate compliance risks, anticipate business impacts, and build robust documentation for successful EU market access.
Features
- Interpret EU IVDR framework and its impact on IVD manufacturers.
- Classify devices under the new IVDR risk-based system (Classes A–D).
- Build compliant performance evaluation plans and reports (PEP & PER).
- Anticipate notified body challenges and post-market surveillance requirements.
Target audiences
- Regulatory Affairs and Compliance Teams
- Professionals in Quality Assurance
- Professionals in Clinical Affairs
- R&D and Product Management Teams
Curriculum
- 5 Sections
- 21 Lessons
- 1 Day
- The IVDR Landscape5
- 1.1Overview of EU IVDR (2017/746) – background, objectives, and scope.
- 1.2Key Definitions: IVD, Performance Evaluation, UDI, Conformity Assessment, Notified Body.
- 1.3Transition From Ivdd To Ivdr: Major Differences And Implications.
- 1.4Key Regulatory Pillars: Risk Classification, Performance Evaluation, Post-market Surveillance (Pms), Eudamed.
- 1.5Annex XIII (PER), NB capacity constraints, Notified Body audits, CE marking, SSCP
- Business & Compliance Impact5
- 2.1Risk-based classification: Classes A, B, C, D → real-world impact on submissions.
- 2.2Bottlenecks: Notified Body scarcity, extended timelines, documentation burden.
- 2.3Clinical evidence challenges: Scientific validity, analytical performance, clinical performance.
- 2.4Post-market surveillance & vigilance under IVDR.
- 2.5How IVDR is reshaping the EU diagnostic market landscape.
- Case Study – Lessons from Implementation4
- Interactive Simulation & Exercises3
- Wrap-Up & Key Takeaways4
Instructor
