Medical device importers

Importer: a status more demanding
than that of a distributor

MDR regulatory flow: from non-EU manufacturer to end user Five actors connected by a continuous information flow — non-EU manufacturer, EC REP authorised representative, importer, distributor, end user — framed by a EUDAMED ring representing European traceability. EUDAMED · 27 MEMBER STATES · TRACEABILITY EU Declaration of Conformity Mandate agreement Delivery note + UDI Instructions + labelling 01 Non-EU Manufacturer Art. 10 MDR 02 EC REP Authorised Representative Art. 11 MDR 03 Importer Art. 13 MDR 04 Distributor Art. 14 MDR 05 End User Art. 87
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Importer

First EU link in the chain — you are here

Art. 13 MDR
  • Verification of the manufacturer, the EC REP, and conformity
  • Affixing your contact details to the device or its packaging
  • EUDAMED registration + obtaining the SRN
  • Complaints register and vigilance cooperation
View the regulatory flow in text format
  1. Non-EU Manufacturer (Art. 10 MDR) — Design, manufacture, EC REP designation
    • Technical documentation compliant with Annexes II–III
    • EU Declaration of Conformity and CE marking
    • Designation of an EC REP before any EU market placement
  2. EC REP Authorised Representative (Art. 11 MDR) — Legal representative of the manufacturer in the EU
    • Verification of the EU Declaration of Conformity
    • Registration of the manufacturer in EUDAMED
    • Cooperation with competent authorities
    • Single point of contact for corrective actions
  3. Importer (Art. 13 MDR) — First EU link in the chain — you are here
    • Verification of the manufacturer, the EC REP, and conformity
    • Affixing your contact details to the device or its packaging
    • EUDAMED registration + obtaining the SRN
    • Complaints register and vigilance cooperation
  4. Distributor (Art. 14 MDR) — Downstream supply on the EU market
    • Verification of CE marking, labelling and instructions for use
    • Verification that importer contact details are affixed
    • Maintenance of registers of complaints and non-conforming devices
  5. End User (Art. 87) — Healthcare facility, professional, patient
    • Use in accordance with the manufacturer's instructions
    • Reporting of incidents (post-market vigilance)
Framing

Importer, distributor, or both?

Article 2(33) of the MDR defines an importer as any natural or legal person established in the EU who places on the Union market a device originating from a third country. The criterion is straightforward: if you purchase a medical device from a non-EU manufacturer and place it on the EU market, you are an importer. You may combine this role with that of a distributor if you subsequently resell to other EU operators.
Your obligations

What the MDR requires of you, as an importer

Obligation Reference Detail
Verification of the manufacturer and the EC REP Art. 13 §2 Before market placement: verify that CE marking is affixed, that the EU Declaration of Conformity exists, that the manufacturer is identified, that an EC REP is designated in accordance with Article 11, that a UDI has been assigned, and that labelling and instructions for use are compliant.
Affixing importer contact details Art. 13 §3 Include on the device, its packaging or an accompanying document: the importer's name, registered trade name, and registered place of business where they can be contacted.
Storage and transport conditions Art. 13 §5 Ensure that storage and transport conditions do not compromise conformity. Documentation required.
Register of complaints, non-conforming devices and recalls Art. 13 §6 Maintenance of a register. Notification to the manufacturer and EC REP of complaints received. Mandatory transmission of relevant information.
EUDAMED registration Art. 31 Registration of the importer in EUDAMED, obtaining a SRN (Single Registration Number).
Cooperation with authorities Art. 13 §10 Making the EU Declaration of Conformity available upon request, cooperating with corrective actions and surveillance measures.
Action in the event of non-conformity Art. 13 §7 If you consider a device to be non-conforming: do not place it on the market, inform the manufacturer and EC REP, and notify the competent authority if there is a serious risk.
Warning Art. 16 MDR

When the importer becomes a manufacturer

Article 16 of the MDR is a frequent trap. Certain operations that you consider routine can legally shift your status from importer to manufacturer, with all the obligations that entails.

Three concrete cases that trigger Article 16

  1. 01

    Repackaging

    You open the primary packaging, repackage, group several devices into a kit, or modify the commercial presentation of the device as it was placed on the market by the manufacturer.

  2. 02

    Affixing your own brand

    You market the device under your own name or brand — whether a white-label product, a distributor label or partial rebranding. As soon as your name appears as the manufacturer on the labelling, you assume the full extent of the MDR obligations.

  3. 03

    Change of intended purpose or modification

    You modify the intended purpose of the device, combine it with another product to create a system, or carry out a modification liable to affect conformity with MDR requirements.

Immediate consequences

  • You assume the full manufacturer obligations under the MDR: QMS, technical documentation, EU Declaration of Conformity, CE marking, post-market surveillance.
Our missions

How we work with medical device importers

Article 13 Diagnostic

Full audit of your Article 13 compliance: verification of manufacturer documentation, EC REP, labelling, EUDAMED, traceability, registers.

Duration 3 to 7 days

Non-EU Manufacturer Qualification Procedure

Building a qualification process for extra-EU manufacturers: documentary checklist, EC REP verification, supplier audit where critical.

Duration 4 to 10 weeks

EUDAMED Registration and Maintenance

Importer registration in EUDAMED, SRN obtainment, annual update, notification management.

Duration 2 to 4 weeks for initial registration

Preparation for a competent authority inspection

Preparation for competent authority inspections. Document review, simulation, team training.

Duration 4 to 8 weeks
Quick diagnostic

Three signals that justify a rapid scoping session

  • You are not registered in EUDAMED or do not have a SRN
  • You do not affix your contact details to imported devices or their packaging
  • You have no formalised complaints and incidents management procedure
Let's discuss your situation
FAQ

Frequently asked questions

The importer is the first EU link in the chain and therefore carries out in-depth verification of the non-EU manufacturer and the EC REP. They affix their contact details and register in EUDAMED. The distributor operates downstream: they verify that the importer contact details are properly affixed and that labelling is compliant, but their obligations are less extensive. Importer = first EU entry point, extended responsibilities.
Yes, and this is actually common. A company that purchases from a non-EU manufacturer and subsequently resells to wholesalers holds both statuses. As a result, it must comply with both Article 13 and Article 14. We structure procedures to cover both.
The importation is illegal. Article 11 of the MDR requires non-EU manufacturers to designate an EC REP before any EU market placement. If you import without verifying this, you engage your own liability and that of the manufacturer. We can propose an EC REP solution (see EC REP page) or refer you to a colleague depending on your situation.

A non-EU manufacturer to qualify, a regulatory inspection to prepare for?

The initial scoping session is free. Present your situation and we will confirm within 48 hours whether a mission is relevant.

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See also: Advisory services · Distributors · EC REP Authorised Representative · Manufacturers