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.

Why it matters

These duties apply to every actor in the supply chain - not just the manufacturer - and are commonly cited in EU competent authority enforcement actions.

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.

Sources

MDR Article 13/14 · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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