MDCG 2020-16: Classification rules for IVDs, explained
How to classify an IVD under IVDR Annex VIII, including software, companion diagnostics and multi-purpose products.
MDCG 2020-16 Rev.4 explains how to apply the seven IVDR classification rules. Classification starts with the exact intended purpose and the risk of an erroneous result. Apply every relevant rule and implementing rule; where more than one classification applies, the highest class governs.
Who this applies to
This guidance is for manufacturers classifying IVDs under Annex VIII IVDR and for notified bodies and authorities reviewing those decisions. It covers classes A, B, C and D. It does not decide whether the product is an IVD in the first place; use the qualification analysis before classification.
Rev.4, published in March 2025, is the current version. It expands rationales and examples, including self-testing, near-patient testing, companion diagnostics and the consequences of erroneous results.
Intended purpose drives the rules
Write the intended purpose with enough precision to classify the device: analyte or marker, function, disease or condition, target population, specimen, intended user, test environment and the role of the result in patient management.
Then apply all potentially relevant rules and sub-rules. If several rules produce different classes, the highest class applies. Do not classify from a product name or a competitor's apparent class; small intended-purpose differences can change the result.
The seven rule families
Rule |
Main territory |
Typical result |
|---|---|---|
1 |
High public-health-risk transmissible agents, including donor screening and specified life-threatening infections |
Class D |
2 |
Blood-grouping and tissue-typing markers |
Class C or D depending on the marker |
3 |
High individual-risk uses such as companion diagnostics, cancer, genetic testing, disease staging and critical patient management |
Class C |
4 |
Self-testing and near-patient testing |
Self-tests usually C with listed B exceptions; near-patient tests follow their underlying rule |
5 |
Specimen receptacles, IVD instruments and specified laboratory products |
Class A |
6 |
Devices not covered by Rules 1–5 |
Class B |
7 |
Controls without an assigned quantitative or qualitative value |
Class B |
Rule 6 is a residual rule, not the default starting point. Document why Rules 1–5 do not apply before using it.
Self-testing and near-patient testing are different
Most devices intended for self-testing are class C. The listed exceptions—pregnancy, fertility and cholesterol tests, plus urine tests for glucose, erythrocytes, leucocytes and bacteria—are class B unless a higher rule applies. A self-test for HIV remains class D because Rule 1 governs.
Near-patient testing does not create a single class. Classify the intended purpose in its own right: a bedside HIV test may be D, a patient-monitoring glucose test C and a low-risk urine dipstick B.
Software follows the information it provides
IVD software is classified on its intended purpose and the significance of the information it generates. Software that drives or influences an IVD generally follows the device under the implementing rules; standalone software is classified in its own right. Record the input data, output, user, decision and plausible consequence of an incorrect, delayed or missing result.
What this means for you, practically
- Qualify first. Confirm that the product, accessory, instrument or software is within the IVDR before selecting a class.
- Create a classification facts sheet. Capture analyte, specimen, population, user, setting, medical function and consequence of error.
- Assess every rule. Quote the decisive language and state why each plausible rule applies or does not.
- Apply the highest result. Include implementing rules for combinations, accessories, software, calibrators and controls.
- Reassess under change control. A new specimen, user, claim, population, algorithm or patient-management role can change the class and conformity route.
For broader qualification boundaries, continue with MDCG 2024-11.
Related MDCG guidance
Related resources
MDCG guidance
MDCG 2021-24: Classification of medical devices
How the MDR classification rules in Annex VIII apply in practice, rule by rule.
MDCG guidance
MDCG 2024-11: Qualification of in vitro diagnostic medical devices
How intended purpose and product characteristics determine whether a reagent, instrument, specimen container, kit, collection device or software is an IVD.
IVDR Classification: Classification Of In-Vitro Diagnostic Devices
Sebastian Skorka
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