IVDR Essentials — In Vitro Diagnostic Regulation
The In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) replaced the previous In Vitro Diagnostic Directive (98/79/EC) and fundamentally changed how IVD medical devices are classified, assessed, and monitored in the European Union. This module covers everything specific to the IVDR that goes beyond what the MDR addresses.
Select your perspective:
From IVDD to IVDR — What Changed?
The previous In Vitro Diagnostic Directive (98/79/EC) used a list-based classification system (Annex II Lists A and B) where approximately 80% of IVDs were self-certified by manufacturers without Notified Body involvement. The IVDR introduces a risk-based classification system similar to the MDR approach, dramatically increasing the proportion of IVDs requiring Notified Body assessment.
| Aspect | Old IVDD (98/79/EC) | New IVDR (EU 2017/746) |
|---|---|---|
| Classification System | List-based (Annex II Lists A & B + self-testing + general) | Risk-based rules (Annex VIII) — 7 classification rules, 4 classes (A–D) |
| Notified Body Involvement | ~20% of IVDs needed Notified Body | ~80% of IVDs now need Notified Body assessment |
| Performance Evaluation | Minimal requirements | Rigorous performance evaluation required (Annex XIII) |
| Post-Market Surveillance | Limited obligations | Full PMS system with PMPF (Annex XIII Part B) |
| Clinical Evidence | Often based on literature only | Performance studies may be required (Article 58–77) |
| EUDAMED | No central database | Mandatory registration in EUDAMED (Article 30) |
| Unique Device Identification | Not required | UDI mandatory (Article 24) |
| Transition Period | N/A | Staggered: Class D by May 2025, Class C by May 2026, Class B/A by May 2027 (extended) |
Key Impact
The shift from list-based to rule-based classification means many IVDs that were previously self-certified now require Notified Body assessment. This has created significant capacity challenges for Notified Bodies and is one reason for the extended transition periods. Under the IVDD, only about 8% of IVDs were in the higher-risk categories. Under the IVDR, that figure rises to approximately 80%.
IVDR Classification System (Annex VIII)
The IVDR classifies IVDs into four risk classes (A, B, C, D) based on seven classification rules set out in IVDR Annex VIII. Classification is determined by the intended purpose of the device and its inherent risks, moving from a prescriptive list approach to a principles-based system.
Class A — Lowest Risk
Self-assessment by manufacturer (no Notified Body required)
IVDs for which defective results do not lead to direct danger for the individual patient or public health. These are typically general laboratory products.
Conformity assessment: Manufacturer self-declaration (IVDR Annex IX, Section A)
Class B — Low-Moderate Risk
Notified Body assessment required
IVDs where incorrect results could lead to indirect risk to the patient or public health, or where the device is used in settings that affect patient management but not as the sole determinant of a critical decision.
Conformity assessment: Notified Body via IVDR Annex IX (quality management) or Annex XI (type examination)
Class C — Moderate-High Risk
Notified Body assessment required
IVDs where incorrect results could lead to direct risk to the patient. Includes self-testing IVDs, companion diagnostics, genetic tests, and devices for screening of congenital disorders.
Conformity assessment: Notified Body via IVDR Annex IX or Annex XI. Companion diagnostics require additional consultation with medicines authority.
Class D — Highest Risk
Notified Body assessment + EU Reference Laboratory verification
IVDs where incorrect results could pose a serious public health threator high risk to individuals. These detect life-threatening conditions or agents transmissible through blood, organs, or tissues.
Conformity assessment: Notified Body via IVDR Annex IX + EU Reference Laboratory batch verification for certain devices (IVDR Article 100). This is the highest level of scrutiny in the IVDR.
Why Classification Matters to You
As a laboratory professional or healthcare worker, understanding IVD classification helps you appreciate the level of regulatory scrutiny behind the tests you rely on daily. Higher-class IVDs (C and D) have undergone more rigorous independent assessment, which is important when evaluating result reliability and making procurement decisions. If you notice performance issues with IVDs in your laboratory, the class of the device influences how urgently the manufacturer and competent authority need to respond.
The Seven Classification Rules (IVDR Annex VIII, Chapter III)
Classification is determined by the intended purpose of the device. Where multiple rules apply, the highest resulting class takes precedence (IVDR Annex VIII, Section 2.4).
IVDR Key Regulatory References
IVDR (EU) 2017/746 — Key Articles
Key IVDR Annexes
MDCG Guidance Documents (IVDR-specific)
Key Takeaways
For Your Daily Practice
- IVDs are now classified A\u2013D based on risk, not just listed in Annexes
- More IVDs undergo Notified Body review \u2014 greater independent assurance
- Companion diagnostics should match the SmPC of the corresponding drug
- Self-testing IVDs have enhanced lay-person usability requirements
- Some IVDs may be discontinued during the transition \u2014 plan ahead
For Your Laboratory
- Check that IVDs have valid CE marking (IVDD during grace period, IVDR after)
- Request performance evaluation summaries from manufacturers
- Near-patient testing still requires quality management and training
- Report IVD incidents to the manufacturer and competent authority
- Cooperate with manufacturer PMPF (post-market performance follow-up) activities
Irish Context — IVD Regulation & the HPRA
The HPRA regulates IVDs in Ireland under IVDR (EU) 2017/746. Laboratories and hospitals using IVDs should verify that products carry the correct IVDR CE marking.
In-house manufactured IVDs (e.g., laboratory-developed tests) used within HSE facilities now fall under IVDR Article 5(5) and must meet specific requirements.
Useful HPRA Links:
This is educational content only and is not an accredited or externally verified course. Always refer to official HPRA publications and your facility's own policies.