IVDR Art. 47
Classification of in vitro diagnostic devices
IVDR classification rules, from class A (lowest risk) to class D (highest)
- Category
- Founding texts
- Market
- European Union
- Applicable classes
- Class A IVD, Class B IVD, Class C IVD, Class D IVD
- Applicable since
- May 26, 2022
In practice
Classification is based on intended purpose, individual and public health risk, and self-testing. Class D covers blood grouping, HIV and prenatal screening. MDCG 2020-16 is the reference guidance.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0746#d1e6567-1-1See where this text lands in your roadmap
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