--- title: "MDR Article 117, Definition | MedTech Terms" description: "EU MDR provision adding device-component requirements to the EU pharma marketing authorization process. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. MDR Article 117 [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # MDR Article 117 EU MDR provision adding device-component requirements to the EU pharma marketing authorization process. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/notified-body) opinion on the device portion's conformity with relevant [MDR](/terms/mdr-reporting) [General Safety and Performance Requirements](/terms/gspr) before marketing authorization. What the regulation says [MDR](/terms/mdr-reporting) 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](/terms/gspr) (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 What is the primary impact of MDR Article 117? The primary impact is the mandatory assessment by a [Notified Body](/terms/notified-body) of the device part of an integral drug-device [combination product](/terms/combination-product), ensuring its compliance with EU [MDR](/terms/mdr-reporting) [General Safety and Performance Requirements](/terms/gspr) before marketing authorization for the medicinal product. Does Article 117 apply to all combination products? Who issues the Notified Body opinion? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ 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. ](/terms/510k-summary-vs-statement)[ 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. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 IMDRF· 1 RAPS· 1 1. [1 EU MDR Article 117 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mdr-article-117) Learn in 60 seconds Card Lesson Quiz EU MDR provision adding device-component requirements to the EU pharma marketing authorization process. - · Forces drug-device combination products into earlier and tighter coordination between pharma and device regulatory teams in Europe. Remember this Watch out: A common pitfall is underestimating the time and resources required for Notified Body involvement in the marketing authorization process for drug-device combinations. Related terms - [Combination Product ](/terms/combination-product) - [EU Medical Device Regulation(MDR) ](/terms/mdr) You may also need Auto-suggested from Regulatory and shared keywords. - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [CE Mark ](/terms/ce-mark) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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