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    MDR Article 117

    EU MDR provision adding device-component requirements to the EU pharma marketing authorization process.

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

    Definition

    Article 117 amends Directive 2001/83/EC so that a medicinal product containing an integral device component (e.g., prefilled pen, drug-eluting stent) requires a Notified Body opinion on the device portion's conformity with relevant MDR General Safety and Performance Requirements before marketing authorization.

    What this means in practice

    Forces drug-device combination products into earlier and tighter coordination between pharma and device regulatory teams in Europe.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1IMDRF·1RAPS·1
    1. 1
      EU MDR Article 117
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

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