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    EU In Vitro Diagnostic Regulation

    Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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

    Definition

    Regulation (EU) 2017/746 (IVDR) sets out the regulatory framework for in vitro diagnostic medical devices in the European Union, replacing Directive 98/79/EC.

    What this means in practice

    IVDR significantly expanded the scope of devices requiring Notified Body involvement and tightened performance evaluation, post-market performance follow-up, and transparency requirements.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Contains

    Sub-elements or required artefacts of this term.

    Often confused with

    Distinct concept frequently mistaken for this one.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1RAPS·1FDA·1
    1. 1
      Regulation (EU) 2017/746
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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