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    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 May 5, 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.

    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.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1FDA·1European Commission·1
    1. 1
      MDR Article 13/14
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.