MDR Article 117
EU MDR provision adding device-component requirements to the EU pharma marketing authorization process.
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. The certificate or notified body opinion (NBOp) goes into the marketing authorization application for products such as prefilled syringes and inhalers. The medicinal product authority still decides on the product as a whole.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.
- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMore in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1EU MDR Article 117Tier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
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