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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 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.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1FDA·1European Commission·1
    1. 1
      EU IVDR (2017/746)
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.