IVDR device classes — Class A · B · C · D
IVDR 2017/746, Article 47 and Annex VIII. IVDR replaced the old IVDD framework (List A / List B / General Devices) with a risk-based four-class system reflecting the risk posed by the diagnostic information generated.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Why the IVDR classification system changed
Under the old IVDD 98/79/EC, around 80% of IVDs were self-certified with no notified body involvement. IVDR dramatically increases notified body requirements — now required for the vast majority of IVDs. This shift reflects:
- Greater recognition of the clinical impact of diagnostic errors
- The need for standardised performance evaluation across member states
- Alignment with the GHTF/IMDRF global IVD classification framework
Class overview
| Class | Risk level | Notified body required? | Examples |
|---|---|---|---|
| Class A | Lowest | No — self-declaration | General laboratory instruments, specimen receptacles, buffers/wash solutions, general staining reagents |
| Class B | Low-to-medium | Yes (Annex IX or X + XI) | Routine haematology, clinical chemistry, general serology, urine analysis |
| Class C | Medium-to-high | Yes (Annex IX or X + XI, with enhanced requirements) | Blood glucose, CRP, INR monitoring, rubella/toxoplasma serology, PSA, companion diagnostics |
| Class D | Highest | Yes (Annex IX only, with EU reference laboratory review) | Blood group typing (ABO, Rh), HIV confirmation, NAT blood screening, hepatitis B/C, CJD detection |
Class A — Self-declaration
Class A IVDs pose the lowest risk because:
- Errors in their use rarely affect individual patient management directly
- They are typically general-purpose instruments or ancillary materials
Class A examples:
- Laboratory balances, centrifuges, and pipettes without a specific IVD claim
- Specimen receptacles (blood tubes, urine cups)
- Buffers, wash solutions, and mounting media
- General histological stains
Class A sterile (Class As): Class A devices supplied sterile require partial notified body involvement — the NB assesses aspects relating to establishing and maintaining sterile conditions only (as with MDR Class Is devices).
Self-declaration obligations for Class A
Manufacturers must still:
- Compile technical documentation (Annex II and III)
- Conduct a performance evaluation (Annex XIII)
- Register in EUDAMED
- Implement a quality management system
- Sign an EU Declaration of Conformity
- Register the device (UDI)
Class B — Notified body required
Class B covers IVDs that support clinical decisions but where errors are unlikely to cause life-threatening harm. Conformity assessment routes available:
- Annex IX: QMS assessment + technical documentation review
- Annex X + Annex XI: EU type examination + production quality assurance
Class B examples:
- Full blood count (FBC) reagents and analysers
- Basic metabolic panel (glucose, urea, creatinine in routine chemistry)
- C-reactive protein (general range)
- General urinalysis strips
- Urine culture media
- Most routine serology tests (not covered by Class C or D)
- ANA (antinuclear antibody) tests
- Rheumatoid factor
Class C — Enhanced notified body assessment
Class C covers IVDs with significant individual patient risk — where an incorrect result could lead to dangerous clinical decisions. Notified body assessment is required, with greater depth of technical documentation review.
Class C specific requirements
For Class C devices, the notified body must:
- Assess the complete performance evaluation (not just a representative sample)
- Review the clinical evidence underpinning performance claims
- For companion diagnostics: consult EMA or a national medicines authority (mandatory) before issuing the certificate
Class C examples:
- Blood glucose self-monitoring systems (including CGM systems that output values)
- HbA1c tests
- PSA (prostate-specific antigen)
- Troponin (cardiac)
- CRP at clinical decision thresholds
- Rubella IgM, toxoplasma, cytomegalovirus serology
- BRCA1/BRCA2 (for patient selection for medicinal products → companion diagnostic: Class C)
- SARS-CoV-2 antigen rapid tests (for diagnosis)
- Near-patient INR monitoring
- Influenza A/B rapid tests
Class D — Highest risk, EU reference laboratory review
Class D covers IVDs where errors could cause life-threatening harm or carry a risk of propagating life-threatening disease. This class requires:
- Annex IX only (no alternative Annex X/XI route)
- A review by an EU reference laboratory designated by the European Commission, before the notified body can issue a certificate
- The reference laboratory assesses batch testing performance and verifies the notified body's assessment
EU Reference Laboratories (EURLs)
EURLs are designated by the European Commission to support the highest-risk IVD categories. They are not routine testing laboratories — they provide specialist scientific oversight and can test representative samples from production batches.
Class D examples:
- Blood group and Rh typing reagents (ABO, Rh, Kell, Duffy, Kidd)
- HIV-1/HIV-2 confirmation (Western blot, supplemental assays)
- Nucleic acid amplification tests (NAT) for HIV, HBV, HCV used in blood screening
- HTLV-I/II tests
- CJD (Creutzfeldt-Jakob disease) detection
- Hepatitis B surface antigen confirmation
- Tests for West Nile virus, dengue, Zika in blood/organ donation screening
Comparing IVDR to IVDD classification
| IVDD category | IVDR equivalent | NB requirement change |
|---|---|---|
| List A (e.g. HIV, HBV, HCV, blood groups) | Class D | Maintained / strengthened (EU reference lab added) |
| List B (e.g. rubella, toxoplasma, glucose) | Class C | Substantially increased (NB now required for most) |
| Self-test devices | Class C or D depending on analyte | Increased |
| General devices (all others) | Class A or B | Increased for Class B |
The practical consequence: manufacturers of formerly self-certified IVDs needed to engage notified bodies for the first time under IVDR.
Transitional provisions note
IVDR applied from 26 May 2022, but with staggered transition deadlines for legacy IVDD-certified devices. See Transitional provisions & timelines for current deadlines.
Related pages
- How classification works
- Classification rules 1–7
- Performance evaluation
- Companion diagnostics
- Conformity assessment — overview
Official references
| Reference | Description |
|---|---|
| IVDR Art. 47 | Classification of IVDs |
| IVDR Annex VIII | Classification rules 1–7 |
| IVDR Art. 48 | Conformity assessment procedures |
| IVDR Art. 48(3) | Companion diagnostic consultation procedure |
| IVDR Art. 100 | EU reference laboratories |
| MDCG 2020-16 | Guidance on companion diagnostics |