All terms
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.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMore in Regulatory
· Same categoryRegulatory
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
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.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Cited by
Where this term appears across MedTech Terms.
Ecosystems (2)
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
Inline markers like [1] jump to the matching reference above.