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. Classification follows seven rules in IVDR Annex VIII. Class D covers the highest risk tests, such as blood screening for transmissible agents; Class C includes companion diagnostics and many cancer and genetic tests; Class B covers moderate risk devices; Class A covers lower-risk products such as specimen receptacles. Self-testing and near-patient devices often fall into a higher class. All classes except non-sterile Class A need a notified body.

Why it matters

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.

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.

Sources

EU IVDR (2017/746) · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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