IVD Risk Classification under EU IVDR: Class A, B, C & D
The risk class of your in vitro diagnostic decides whether you need a Notified Body, which conformity route applies and how much performance evidence you need. We classify your IVD against all seven Annex VIII rules and document the justification.
How IVD risk classification works
Under the EU IVDR, every in vitro diagnostic falls into one of four classes: Class A (lowest risk) to Class D (highest risk). The class reflects the risk to the individual patient and to public health if the result is wrong.
This replaced the old IVDD list-based system, where most IVDs were self-declared. Many devices have moved up a class, so a legacy IVD's status under the IVDD cannot be assumed to carry over.
IVD risk classes explained
Each class has its own conformity route. Sterile Class A devices need a Notified Body for their sterility aspects only.
| Class | Risk | Example devices | Notified Body |
|---|---|---|---|
| Class A | Low individual and public health risk | Specimen receptacles, buffer and washing solutions, general culture media, IVD instruments | No (yes if sterile) |
| Class B | Moderate individual, low public health risk | Pregnancy, fertility, cholesterol and glucose self-tests, controls without assigned values | Yes |
| Class C | High individual or moderate public health risk | Cancer markers, genetic tests, companion diagnostics, STI tests | Yes |
| Class D | High individual and high public health risk | HIV and hepatitis blood screening, ABO and Rhesus blood grouping | Yes, plus EU reference laboratory |
The 7 Annex VIII rules for IVDs
Every IVD is checked against each rule. If more than one applies, the highest class applies.
| Rule | Class | What it covers |
|---|---|---|
| Rule 1 | D | Transmissible agents in blood, cells, tissues or organs for transfusion or transplantation; life-threatening transmissible agents with a high risk of spread; infectious load where monitoring is critical. |
| Rule 2 | C or D | Blood grouping and tissue typing for compatibility. Class D for ABO, Rhesus, Kell, Kidd and Duffy systems; otherwise Class C. |
| Rule 3 | C | Sexually transmitted agents, infectious disease, companion diagnostics, cancer screening and staging, genetic testing, drug monitoring, life-threatening disease management and congenital disorder screening. |
| Rule 4 | B or C | Self-tests are Class C, except pregnancy, fertility, cholesterol, glucose and urine erythrocyte, leucocyte or bacteria tests (Class B). |
| Rule 5 | A | General laboratory products, buffer and washing solutions, culture media and stains for IVD use, IVD instruments and specimen receptacles. |
| Rule 6 | B | Any IVD not covered by the rules above. |
| Rule 7 | B | Controls without a quantitative or qualitative assigned value. |
How we classify your IVD, step by step
A defensible classification that your Notified Body can accept without debate.
- 1
Define the intended purpose
FoundationWe pin down the analyte, specimen, target population, intended user and clinical use from your labels, IFU and claims.
- 2
Apply every rule
Rules 1–7We check each rule and take the highest class where several apply.
- 3
Check the implementing rules
Annex VIII, Chapter IWe classify accessories, calibrators, controls and software correctly.
- 4
Use MDCG guidance
MDCG 2020-16We test the result against the latest MDCG classification guidance and examples.
- 5
Write the classification rationale
Technical documentationWe document the rules applied and the reasoning, ready for your Notified Body.
- 6
Confirm the conformity route
Next stepWe map the class to the right Annex IX, X or XI route and a realistic CE marking plan.
Common IVD classification mistakes
Our IVD classification services
IVD risk classification FAQs
How many classification rules are there for IVDs under IVDR?
IVDR Annex VIII has 7 classification rules. Each IVD is checked against all of them, and if more than one applies, the highest class applies.
Which IVDs are Class D?
Class D covers the highest-risk IVDs: tests for transmissible agents in blood, tissues or organs for transfusion or transplantation, tests for life-threatening transmissible agents with a high risk of spread, and blood grouping for ABO, Rhesus, Kell, Kidd and Duffy systems.
How are self-tests classified under IVDR?
Under Rule 4, self-tests are Class C, except tests for pregnancy, fertility, cholesterol, glucose and urine erythrocytes, leucocytes or bacteria, which are Class B.
Are companion diagnostics Class C?
Yes. Under Rule 3, companion diagnostics are Class C. The Notified Body must also consult the EMA or a national medicines authority before issuing the certificate.
How is IVD software classified?
Software that drives or influences an IVD takes the same class as the device. Standalone software is classified in its own right using the same seven rules. MDCG 2019-11 gives guidance on qualifying and classifying software.
Who decides the class of an IVD?
The manufacturer classifies the device and justifies it in the technical documentation, using guidance such as MDCG 2020-16. The Notified Body checks it, and disputes go to the competent authority under IVDR Article 47(2).
Not sure which class your IVD falls into?
Send us your intended purpose using the form below and we'll confirm its IVDR class at no cost.
