What are examples of devices in each class?

Class A includes general laboratory reagents, Class B infectious disease self-tests like for Lyme, Class C many common infectious disease tests, and Class D blood screening assays or tests for highly dangerous pathogens.

What is the role of Common Specifications?

Common Specifications (CS) are technical and clinical requirements that provide a means of complying with the IVDR. For Class D devices, compliance with relevant CS is generally mandatory, and they also apply to specific analytes, regardless of the device class, as specified in relevant implementing acts.

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IVDR Risk Classes A–D

EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Under EU IVDR (2017/746), IVDs are classified A, B, C, or D based on intended purpose and risk to individuals and public health. Class B and above generally require Notified Body involvement.

What the regulation says

The EU In Vitro Diagnostic Regulation (IVDR, 2017/746) outlines a risk-based classification system for in vitro diagnostic medical devices, categorizing them into four classes: A, B, C, and D. This classification is determined by the device's intended purpose and the risks it poses to individual and public health, as detailed in IVDR Annex VIII. Regulators expect manufacturers to correctly classify their devices as this dictates the conformity assessment route and the level of Notified Body involvement required.

What this means in practice

IVDR shifted ~80% of IVDs into Notified Body oversight (vs. ~20% under IVDD), creating sustained capacity strain. Common Specifications apply for Class D devices and certain analytes.

Examples

A manufacturer of a new immunoassay for detecting a highly transmissible and dangerous virus would classify it as Class D, necessitating stringent conformity assessment, including Notified Body involvement and potentially expert panel review.
A company developing a self-test for monitoring blood glucose levels for diabetic patients would likely classify it as Class B due to the moderate individual risk, requiring Notified Body assessment for conformity.
A producer of a general-purpose laboratory instrument, such as a centrifuge, used in IVD procedures but not an IVD itself, would likely have its associated consumables classified as Class A.

Common pitfalls

•Misclassifying an IVD can lead to significant regulatory hurdles, including delays in market access or non-compliance penalties.
•Underestimating the evidence required for higher risk classes, particularly for Class C and D devices, is a common pitfall.
•Failing to consider all aspects of the intended purpose when determining the risk class can result in an incorrect classification.
•Neglecting to update the risk classification if the intended purpose or technology of the IVD changes can lead to non-conformity.
•Assuming that a device's classification under the IVDD automatically translates to the same class under the IVDR is incorrect due to the stricter IVDR rules.

Frequently asked questions

The IVDR introduced a significantly stricter classification system compared to the IVDD, reclassifying approximately 80% of IVDs into higher risk categories that require Notified Body oversight, whereas under the IVDD only about 20% did.

Cross-references

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EU In Vitro Diagnostic Regulation(IVDR)

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EU In Vitro Diagnostic Regulation(IVDR)

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EUR-Lex·1FDA·1European Commission·1

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