The EU IVDR 2017/746 replaced Directive 98/79/EC on May 26, 2022, introducing a stricter regulatory framework for In Vitro Diagnostic (IVD) devices in the EU. It reclassifies IVDs into four risk-based classes (A, B, C, D), increases Notified Body involvement especially for higher-risk devices, and mandates robust clinical evidence along with post-market surveillance. Transparency and traceability are enhanced via the European Database on Medical Devices (EUDAMED) and Unique Device Identifiers (UDI).
Key Objectives
- Enhance Patient Safety: Ensure all IVDs meet strict safety and performance standards.
- Increase Regulatory Oversight: Classify devices by risk with greater Notified Body involvement.
- Ensure Robust Clinical Evidence: Manufacturers must provide detailed clinical data proving device safety and effectiveness.
- Strengthen Post-Market Surveillance: Monitor device performance and address safety issues quickly.
- Improve Transparency and Traceability: Use EUDAMED and UDI for better tracking.
- Align with Global Standards: Harmonize EU regulations with international best practices.
IVDR Medical Device Classification
| Class | Risk Level | Description | Examples | CE Marking Route |
|---|---|---|---|---|
| A | Low Risk | Non-invasive, minimal risk | Blood glucose reagents, pregnancy tests, urine strips, specimen containers | EU Declaration of Conformity [Annex III] (excluding sterile) |
| B | Moderate Risk | More complex tests, moderate risk | HIV test kits, fertility tests, cholesterol strips, hepatitis B/C kits | Quality Management System + Technical Documentation [Annex IX] |
| C | High Risk | Critical diagnostic tests | Cancer biomarkers, genetic tests, infectious disease tests | Routes including [Annex IX, X, XI] plus competent authority consultation for companion diagnostics |
| D | Very High Risk | Highest risk, critical patient impact | HIV viral load, antimicrobial resistance tests, prenatal chromosomal tests, transplant compatibility | Similar to Class C plus verification by EU Reference Laboratory |
IVDR Classification Rules Highlights
- Rule 1: Class D — Devices detecting infectious agents or infectious load of life-threatening diseases.
- Rule 2: Class C/D — Blood grouping and tissue typing for transfusions/transplants.
- Rule 3: Class C — STDs detection, prenatal screening, cancer diagnostics, genetic testing.
- Rule 4: Class B/C — Self-testing devices (excluding pregnancy, fertility tests).
- Rule 5: Class A — Laboratory reagents, instruments, specimen containers.
- Rule 6: Class B — Devices not covered by other rules.
- Rule 7: Class B — Devices used as controls without assigned values.
Why IVDR Compliance Matters for Your Business
Medral Global supports manufacturers in navigating the IVDR landscape, ensuring your IVD products meet EU standards, enabling market access and improving patient safety.