Are there specific record-keeping requirements for importers and distributors?

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.

How do these obligations relate to EUDAMED?

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.

What happens if an importer or distributor fails to meet these obligations?

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.

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RegulatoryRegulated Pathways Post-Market & Safety 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 CyberLast reviewed September 19, 2026

Definition

Articles 13 and 14 of MDR (and parallel IVDR articles) require importers to verify CE marking, EC REP designation, labeling, and 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. Under MDR and IVDR Articles 13 and 14, importers must check that devices are CE marked, registered in EUDAMED, labeled correctly and have an authorised representative, and must put their own name and address on the device or packaging. Distributors must verify similar items by sampling. Both must keep complaint registers, cooperate on corrective actions and report suspected serious incidents to the manufacturer. Some relabeling or repackaging activities make them subject to Article 16.

What the regulation says

The EU Medical Device Regulation (MDR) 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. 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

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 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.

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Authorized Representative (EU)(EC REP)

Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes.

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EU Medical Device Regulation(MDR)

Regulation (EU) 2017/745 governing medical devices in the European Union.

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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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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.

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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.
·Distributors must verify similar items by sampling.

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.

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