IVDR Classification
IVDR classification sorts every in vitro diagnostic device into risk class A, B, C or D using the seven rules in Annex VIII of Regulation (EU) 2017/746. The class you land in decides whether a notified body is involved, which conformity assessment route you follow and how much technical and performance evidence you need. This guide walks through the classes, the rules and how to document your decision.
The basics
What is IVDR Classification?
EU IVDR classification is based on the intended purpose of the device and its inherent risks, both to the individual patient and to public health. Manufacturers must classify their in vitro diagnostic devices using the rules in Annex VIII of Regulation (EU) 2017/746. The lowest-risk devices sit in Class A and the highest-risk devices, such as tests used to screen donated blood, sit in Class D.
The classification system is one of the biggest changes from the old IVD Directive (98/79/EC). Under the IVDD, only devices on Annex II List A and List B, and self-tests, needed a notified body; around 80% of IVDs were self-declared. The IVDR follows the rule-based approach developed by the GHTF/IMDRF, and now roughly 80% of IVDs (Class B, C and D) need a notified body before they can carry the CE mark.
Because the class drives everything else in your IVDR CE marking project, from the conformity assessment route to the depth of the technical documentation and performance evaluation, getting IVDR classification right is the first task in any IVDR project.
Watch: IVDR classification of in vitro diagnostic devices (I3CGlobal)
IVDR Risk Classes A, B, C and D
Each IVDR classification class carries a different level of risk and a different level of notified body involvement. Select a class to read its detailed requirements, conformity assessment routes and transition provisions.
Class A sterile devices
A Class A device supplied sterile still needs a notified body, but only for the aspects of manufacture that establish and maintain sterility. Read our IVDR Class A sterile guide.
IVD software
Software that drives or influences an IVD takes the class of that device; standalone IVD software is classified in its own right using the same rules. See IVD software device guide.
IVDR Classification Table: Classes, Examples and Conformity Assessment
Use this IVDR classification table to see how the class changes the route to CE marking. Notified body involvement increases with each class.
| Class | Risk level | Typical examples | Conformity assessment route | Notified body |
|---|---|---|---|---|
| Class A | Low patient risk, low public health risk | Buffers, washing solutions, culture media, histological stains, general IVD instruments, specimen receptacles | Manufacturer’s self-declaration (Annex II and III technical documentation, Annex IV declaration of conformity) | No (except sterile aspects for Class A sterile) |
| Class B | Moderate patient risk, low public health risk | Clinical chemistry analytes, pregnancy and fertility self-tests, urine glucose self-tests, controls without assigned values | Annex IX QMS audit with technical documentation assessment of at least one representative device per category. Self-test and near-patient devices are reviewed for every device (Annex IX, Section 5.1). | Yes |
| Class C | High patient risk, moderate public health risk | Cancer markers, genetic tests, companion diagnostics, prenatal screening, STI tests, most self-tests | Annex IX QMS audit plus technical documentation assessment of at least one device per generic device group, or Annex X type examination plus Annex XI production quality assurance. Self-test, near-patient and companion diagnostic devices are assessed for every device. Companion diagnostics also require consultation with a competent authority or the EMA (Annex IX, Section 5.2). | Yes |
| Class D | High patient risk, high public health risk | HIV, HBV, HCV blood-donor screening, ABO and Rhesus blood grouping, tests for highly infectious agents | Annex IX with full technical documentation assessment, EU reference laboratory performance verification, batch verification and expert panel consultation for novel devices | Yes |
Costs and timelines rise with the class. Our IVDR CE certification cost page explains the notified body and consulting fees you should budget for each class.
What changed
IVDD Lists vs IVDR Classification
Under the IVD Directive, devices were grouped as Annex II List A, Annex II List B, self-tests and “others”. Only the first three groups needed a notified body, so most manufacturers self-certified. The IVDR replaced those lists with a risk-based system that aligns IVD classification with the GHTF/IMDRF principles already used in other markets.
The practical effect is that many products that were self-certified under the IVDD, such as infectious disease assays, genetic tests and oncology markers, are now Class C and need a notified body for the first time. Manufacturers moving from the IVDD must reclassify every product, update the IVDR technical documentation and plan notified body capacity well before their transition deadline. Our EU IVDR regulation page covers the transition timeline in detail.
EU IVDR Classification Rules 1 to 7 Explained
The responsibility for identifying the risk class of an IVD lies with the manufacturer. For Class B, C and D devices the notified body verifies the classification, and competent authorities may check it for any class, including Class A. Work through all seven EU IVDR classification rules; if more than one rule applies, or the device has several intended purposes, the rule that gives the highest class wins.
Rule 1Class D
Transmissible agents in blood, tissues and organs
- Detection of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, to assess suitability for transfusion, transplantation or cell administration
- Detection of a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation
- Determining the infectious load of a life-threatening disease where monitoring is critical to patient management
Rule 2Class C / D
Blood grouping and tissue typing
- Blood grouping or tissue typing to ensure immunological compatibility for transfusion, transplantation or cell administration: Class C
- Except ABO, Rhesus (C, c, D, E, e), Kell, Kidd and Duffy systems, which are Class D
Rule 3Class C
High individual risk tests
- Sexually transmitted agents, and infectious agents in cerebrospinal fluid or blood with limited propagation risk
- Infectious agents where an erroneous result could cause death or severe disability
- Pre-natal screening of women for immune status, and infective or immune status monitoring for life-threatening disease
- Screening, diagnosis or staging of cancer, and companion diagnostics
- Human genetic testing, and monitoring of medicinal products with a narrow therapeutic index
- Management of patients with a life-threatening disease or condition
- Screening for congenital disorders in the embryo, foetus or newborn where failure to detect leads to severe outcomes
Rule 4Class C / B
Self-testing and near-patient testing
- Devices for self-testing are Class C
- Except self-tests for pregnancy, fertility, cholesterol, and glucose, erythrocytes, leucocytes or bacteria in urine, which are Class B
- Devices for near-patient testing are classified in their own right using the other rules
Rule 5Class A
General laboratory products
- Products for general laboratory use, accessories with no critical characteristics, buffer solutions, washing solutions, general culture media and histological stains intended for IVD procedures
- Instruments specifically intended by the manufacturer for IVD procedures
- Specimen receptacles
Rule 6Class B
Devices not covered by other rules
- Any IVD that is not captured by Rules 1 to 5 defaults to Class B
- Covers most routine clinical chemistry, haematology and immunoassay analytes
Rule 7Class B
Controls without assigned values
- Devices that are controls without a quantitative or qualitative assigned value are Class B
- Calibrators and controls with assigned values follow the class of the device they are intended for
Implementing rules to remember
- Classification is driven by the intended purpose stated by the manufacturer
- Accessories are classified in their own right, separately from the device
- Software that drives or influences a device takes the same class; standalone software is classified on its own
- Calibrators take the class of the device they calibrate
- If several rules apply, the highest class applies
The full legal text is in Annex VIII of Regulation (EU) 2017/746 on EUR-Lex, and the European Commission’s MDCG 2020-16 guidance gives worked examples for borderline devices.
IVDR Classification Examples by Device Type
The IVDR classification examples below show how the rules apply to common products. They are indicative only: the final class always depends on the exact intended purpose stated in your labelling and instructions for use.
| Device | Intended purpose | Rule | IVDR class |
|---|---|---|---|
| HIV, HBV, HCV assay | Screening of donated blood for transmissible agents | Rule 1 | Class D |
| ABO / Rhesus reagents | Blood grouping for transfusion compatibility | Rule 2 | Class D |
| HLA tissue typing kit | Immunological compatibility for transplantation | Rule 2 | Class C |
| BRCA1/2 genetic test | Human genetic testing | Rule 3 | Class C |
| PSA or CA-125 assay | Screening, diagnosis or monitoring of cancer | Rule 3 | Class C |
| Chlamydia / gonorrhoea NAAT | Detection of a sexually transmitted agent | Rule 3 | Class C |
| HbA1c test | Management of patients with diabetes | Rule 3(k) | Class C |
| CRP or procalcitonin assay | Monitoring infection response in a life-threatening condition, such as sepsis | Rule 3(j) | Class C |
| Blood glucose self-test meter | Self-testing from a blood sample | Rule 4 | Class C |
| Pregnancy self-test | Self-testing, listed exception | Rule 4 | Class B |
| Vitamin D assay | Routine clinical chemistry not covered by other rules | Rule 6 | Class B |
| Unassigned-value control material | Control without quantitative or qualitative assigned value | Rule 7 | Class B |
| Culture media, buffers, stains | General laboratory use in IVD procedures | Rule 5 | Class A |
| Blood collection tube | Specimen receptacle | Rule 5 | Class A (sterile) |
Transition deadlines depend on the class
Regulation (EU) 2024/1860 extended the transition for eligible legacy devices. These dates apply only if all conditions are met, including an IVDR-compliant QMS by 26 May 2025 and no significant change in design or intended purpose.
| Class | Notified body application | Written agreement | End of transition |
|---|---|---|---|
| D | 26 May 2025 | 26 September 2025 | 31 December 2027 |
| C | 26 May 2026 | 26 September 2026 | 31 December 2028 |
| B and A sterile | 26 May 2027 | 26 September 2027 | 31 December 2029 |
If you have missed a date, check your legacy device status with your regulatory team or notified body before relying on the transition. See the IVDR transition timeline.
Classification drives performance evidence
Higher classes need deeper scientific validity, analytical performance and clinical performance evidence in the performance evaluation report, and Class D devices are also tested by an EU reference laboratory. Fixing the class early keeps the evidence plan realistic and the certification budget accurate.
How to Classify Your IVD Device Under the IVDR
A defensible IVDR classification is a short, documented exercise, and the same IVDR classification steps work for a single reagent or a full product portfolio. We follow these steps with every client and record the result in the technical documentation.
- Define the intended purposeWrite down what the device detects, in which specimen, for which population and for which clinical decision. Classification follows the intended purpose, not the technology.
- Confirm the device is an IVDCheck the IVDR definition in Article 2 and rule out general laboratory equipment, research-use-only products and medical devices covered by the MDR.
- Apply the implementing rulesDecide whether accessories, software, calibrators and controls are classified separately or take the class of the parent device.
- Test the device against Rules 1 to 7Work through each rule in order and note every rule that applies to any intended purpose of the device.
- Select the highest classWhere several rules apply, the rule that results in the highest class determines the IVDR classification.
- Document the rationaleRecord the rule, the reasoning and any guidance used (for example MDCG 2020-16) in the technical documentation, where the notified body will review it.
Special cases
IVDR Classification of Software, Accessories and Kits
Some products need extra care when applying IVDR classification rules, because the IVDR classification of software, accessories and kits follows the implementing rules rather than Rules 1 to 7 alone:
- Software: software that drives or influences the use of an IVD takes the class of that device. Standalone software, such as an algorithm that interprets genetic variants, is classified in its own right and often lands in Class C. Read our guide to in-vitro diagnostic software devices.
- Accessories: classified separately from the device they support, based on their own intended purpose.
- Kits and systems: a kit is classified according to its overall intended purpose; individual components placed on the market separately are classified on their own.
- Calibrators and controls: calibrators follow the class of the device they are used with; controls without assigned values are Class B under Rule 7.
- Sterile Class A devices: keep Class A but need a notified body for sterility. See IVDR Class A sterile.
Borderline between IVDR and MDR?
Devices that examine specimens taken from the human body are IVDs. Devices that act on the body, or only measure physiological parameters, fall under the MDR and use a different set of classification rules. If you are unsure, the intended purpose and the specimen type usually settle it. Our IVDR consultants can give you a written classification opinion.
Documents that depend on the class
- Technical documentation (Annex II and III)
- Performance evaluation report
- Performance evaluation checklist
- Post-market surveillance and PMPF plans
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Get Your IVDR Classification Confirmed by Experts
Our IVDR consultants classify your devices, document the rationale and build the technical documentation and performance evaluation your notified body expects, for Class A through Class D.
- Written classification rationale for each device
- Conformity assessment route selection
- IVDR technical documentation and PER
- Notified body submission and query support
Confirm your device class
Share your device details and get a tailored proposal. See typical IVDR certification costs.
IVDR Classification: Frequently Asked Questions
Who decides the IVDR classification of a device?
The manufacturer is responsible for the initial IVDR classification, based on the intended purpose defined by its design and development team. For Class B, C and D devices the notified body reviews and confirms the classification, and competent authorities can check it for any class.
Do we need to maintain a technical file for Class A devices?
Yes. Manufacturers of all IVDs, including Class A, must prepare and keep up-to-date technical documentation in line with Annexes II and III, even though no notified body reviews it before CE marking.
Are Class A devices exempt from notified body CE certification?
Class A devices under Rule 5 do not need a notified body and are self-declared. The exception is Class A sterile devices, where a notified body assesses the aspects related to establishing and maintaining sterility.
What happens if the classification is wrong at notified body submission?
Misclassification can cost time, money and credibility. Typical consequences are technical file rejection, delays in CE marking, additional testing or documentation, and possible market withdrawal if the device has already been placed on the market in the wrong class.
What if more than one classification rule applies?
Apply every rule that fits any intended purpose of the device, then use the rule that gives the highest risk class.
How are self-tests classified under the IVDR?
Self-tests are Class C under Rule 4, except tests for pregnancy, fertility, cholesterol, and glucose, erythrocytes, leucocytes or bacteria in urine, which are Class B. Near-patient tests are classified by the other rules according to what they detect.
Is IVDR classification the same as MDR classification?
No. The MDR uses Classes I, IIa, IIb and III with 22 rules for medical devices. The IVDR uses Classes A to D with 7 rules, based on the risk of an incorrect result to the patient and to public health.
Where can I find official guidance on IVDR classification?
Annex VIII of Regulation (EU) 2017/746 contains the rules, and MDCG 2020-16 (Guidance on classification rules for in vitro diagnostic medical devices) gives worked examples from the Medical Device Coordination Group.
Updated | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Swathi Tummala, Senior Regulatory Consultant, I3CGLOBAL