Regulation (EU) 2017/746
IVDR Consulting & Certification
IVD-specific regulatory expertise — from Class A self-declared devices to Class D companion diagnostics.
Scope of work
- IVDR classification (Rule 1-7, Class A-D)
- Technical Documentation (Annex II & III)
- Performance Evaluation Plan & Report (PEP/PER)
- Scientific Validity Report
- Analytical & Clinical Performance studies design
- Common Specifications (CS) compliance
- Notified body selection & submission
- PMS, PMPF & Trend Reporting
Frequently Asked Questions
The amended deadlines run 2025–2029 by class. Class D until May 2025, Class C until May 2026, Class B & A sterile until May 2027. Plan early — notified body capacity is constrained.