--- title: "Importer and Distributor Obligations (EU)… | MedTech Terms" description: "MDR/IVDR places verification, labeling, traceability, and vigilance duties on importers and distributors. 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Distributors, under EU MDR Article 14, are generally responsible for ensuring the CE marking remains visible and readable, and that the device has not been tampered with." } }, { "@type": "Question", "name": "Are there specific record-keeping requirements for importers and distributors?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, both importers and distributors are required to keep a register of complaints, non-conforming devices, withdrawals, and recalls, as specified in EU MDR Articles 13(5) and 14(4). This documentation is crucial for traceability and post-market surveillance." } }, { "@type": "Question", "name": "How do these obligations relate to EUDAMED?", "acceptedAnswer": { "@type": "Answer", "text": "Importers must ensure that the device and the manufacturer are registered in EUDAMED, and they must also register themselves in EUDAMED, as per EU MDR Article 13(2)(c) and Article 31. While distributors are not directly responsible for EUDAMED registration of devices, they must verify that the relevant information is available and accessible." } }, { "@type": "Question", "name": "What happens if an importer or distributor fails to meet these obligations?", "acceptedAnswer": { "@type": "Answer", "text": "Non-compliance can lead to various enforcement actions by national competent authorities, including market withdrawal of devices, fines, or other penalties, as outlined in national legislation implementing the EU MDR." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Importer and Distributor Obligations (EU) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets) # Importer and Distributor Obligations (EU) MDR/IVDR places verification, labeling, traceability, and vigilance duties on importers and distributors. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Articles 13 and 14 of [MDR](/terms/mdr-reporting) (and parallel [IVDR](/terms/ivdr) articles) require importers to verify CE marking, [EC REP](/terms/ec-rep) designation, [labeling](/terms/labeling), and [EUDAMED](/terms/eudamed) registration before placing a device on the EU market, and require distributors to maintain conditions of storage and transport and to react to non-conformities. What the regulation says The [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) Article 13 outlines specific obligations for importers, including verifying the CE marking, the EU authorized representative designation, and ensuring the device is registered in [EUDAMED](/terms/eudamed). Similarly, MDR Article 14 details distributor obligations, such as maintaining proper storage and transport conditions and acting on non-conforming devices. These articles ensure traceability and compliance throughout the supply chain, as highlighted by enforcement actions from EU competent authorities. ## What this means in practice These duties apply to every actor in the supply chain - not just the manufacturer - and are commonly cited in EU competent authority enforcement actions. ## Examples - An importer verifies that a Class IIa surgical instrument bears a valid CE marking and that the manufacturer has appointed an EU authorized representative before making it available in an EU country. - A distributor of in vitro diagnostic medical devices implements specific temperature control procedures for transport and storage to comply with the manufacturer's instructions and maintain device integrity. - Upon receiving a complaint about a malfunctioning infusion pump, a distributor immediately notifies the manufacturer and isolates affected batches, documenting the entire process. Common pitfalls - • Importers often fail to conduct thorough checks of technical documentation before placing devices on the market, assuming the manufacturer has covered all aspects. - • Distributors sometimes overlook the necessity of having a documented quality management system that addresses their specific obligations under the MDR. - • A common mistake is not establishing clear communication channels and agreements with manufacturers regarding non-conformities and corrective actions. - • Some economic operators wrongly assume that these obligations only apply to high-risk devices, rather than all devices covered by the MDR. - • Failure to maintain accurate records of devices supplied and received can lead to significant compliance issues during audits. ## Frequently asked questions What is the primary difference between an importer's and a distributor's obligation regarding CE marking? Importers are primarily responsible for verifying the existence and validity of the CE marking before placing a device on the EU market, as per EU [MDR](/terms/mdr-reporting) Article 13. Distributors, under EU MDR Article 14, are generally responsible for ensuring the CE marking remains visible and readable, and that the device has not been tampered with. Are there specific record-keeping requirements for importers and distributors? How do these obligations relate to EUDAMED? What happens if an importer or distributor fails to meet these obligations? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Authorized Representative (EU)(EC REP) Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. ](/terms/ec-rep)[ 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 (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 1 European Commission· 1 1. [1 MDR Article 13/14 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 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=importer-distributor) Learn in 60 seconds Card Lesson Quiz MDR/IVDR places verification, labeling, traceability, and vigilance duties on importers and distributors. - · These duties apply to every actor in the supply chain - not just the manufacturer - and are commonly cited in EU competent authority enforcement actions. Remember this Watch out: Importers often fail to conduct thorough checks of technical documentation before placing devices on the market, assuming the manufacturer has covered all aspects. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [CE Mark ](/terms/ce-mark) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [EUDAMED ](/terms/eudamed) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Notified Body(NB) ](/terms/notified-body) [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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