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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 the regulation says
MDR Article 117 modifies Directive 2001/83/EC, necessitating that notified bodies issue an opinion on the conformity of the device component of drug-device combination products with the EU MDR General Safety and Performance Requirements (Annex I), prior to the granting of a marketing authorization for the medicinal product. This ensures that the device aspect of these integral products meets EU MDR standards.
What this means in practice
Forces drug-device combination products into earlier and tighter coordination between pharma and device regulatory teams in Europe.Examples
- A pharmaceutical company developing a new insulin pre-filled pen must obtain a Notified Body opinion on the pen's compliance with EU MDR GSPRs as part of its medicinal product marketing authorization application.
- A drug-eluting stent, classified as a drug-device combination product, requires evaluation by a Notified Body regarding the stent's adherence to EU MDR Annex I before the drug can receive marketing authorization.
- When a novel auto-injector is developed for a life-saving drug, the device component's conformity with EU MDR must be verified by a Notified Body under Article 117.
Common pitfalls
- •A common pitfall is underestimating the time and resources required for Notified Body involvement in the marketing authorization process for drug-device combinations.
- •Another mistake is failing to integrate device regulatory experts early in the development lifecycle of a combination product.
- •Companies often err by not adequately preparing technical documentation for the device component to meet EU MDR Annex II and III prior to seeking a Notified Body opinion.
Frequently asked questions
The primary impact is the mandatory assessment by a Notified Body of the device part of an integral drug-device combination product, ensuring its compliance with EU MDR General Safety and Performance Requirements before marketing authorization for the medicinal product.
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Regulatory
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
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Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1IMDRF·1RAPS·1
- 1
EU MDR Article 117VerifiedEUR-Lexeur-lex.europa.eu
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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