IVDR (In Vitro Diagnostic Regulation) Essentials Training by Tonex
Modern diagnostics face fast-moving requirements, global supply chains, and rising expectations from regulators and patients. This program equips professionals to interpret, implement, and maintain compliance with the EU IVDR from classification through post-market performance follow-up.
You will learn to design technical files that stand up to notified-body scrutiny and build risk management into daily operations. Cybersecurity matters to IVDs because connected analyzers, cloud reporting, and LIMS integrations can expose patient data and device integrity. You will practice documenting controls that align safety, performance, and resilience. Strong governance bridges clinical evidence, software lifecycle, and secure data handling.
Learning Objectives
- Understand IVDR scope, definitions, roles, and transition timelines
- Apply classification rules and choose proportionate conformity assessment routes
- Build compliant technical documentation and performance evaluation plans
- Operationalize QMS processes aligned with ISO 13485 and IVDR requirements
- Plan vigilance, PMS, PMPF, and continuous improvement activities
- Strengthen resilience with secure design and data protection practices where cybersecurity is integral to safety and performance
Audience
- Regulatory Affairs Specialists
- Quality Managers and Auditors
- R&D Engineers and Product Owners
- Clinical and Performance Evaluation Leads
- Compliance and Risk Professionals
- Cybersecurity Professionals
Course Modules
Module 1 – IVDR Foundations
- Scope and key terms
- Economic operator roles
- Transition and grace rules
- Legacy device strategy
- UDI and EUDAMED basics
- Harmonized standards map
Module 2 – Classification & Conformity
- Rule-based classification
- Common pitfalls review
- Conformity routes overview
- Notified body selection
- QMS and technical file fit
- Declaration of conformity
Module 3 – Technical Documentation
- GSPR checklist structuring
- Device description clarity
- Design and manufacturing data
- Software and SaMD dossiers
- Labeling and IFU controls
- Change control traceability
Module 4 – Performance Evidence
- PEP and clinical strategy
- Scientific validity building
- Analytical performance data
- Clinical performance studies
- Study documentation quality
- Summary of safety performance
Module 5 – QMS & Risk
- ISO 13485 alignment
- IVDR-specific procedures
- Risk management per ISO 14971
- Usability and human factors
- Supplier and outsourcing control
- CAPA effectiveness checks
Module 6 – PMS, PMPF & Security
- PMS plan and reports
- Vigilance and trend reporting
- PMPF objectives and methods
- Field safety corrective actions
- Data protection by design
- Secure SDLC and patch planning
Ready to operationalize IVDR with confidence and build products that are safe, effective, and resilient in connected healthcare Join Tonex to master the regulation end-to-end, translate it into practical controls, and accelerate compliant market access.