Curriculum
- 5 Sections
- 21 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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
Key Definitions: IVD, Performance Evaluation, UDI, Conformity Assessment, Notified Body.
Next