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Importers

Regulatory basis

Importer obligations are defined in MDR Article 13 and IVDR Article 13. Definitions appear in MDR Article 2(33) and IVDR Article 2(30).

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.

Who is an importer?​

An importer is any natural or legal person established within the EU that places a device from a third country on the EU market.

"Placing on the market" means making a device available for the first time on the EU market — the importer is therefore the first EU-established entity to physically handle a device coming from outside the EU, with the intention of distributing it within the EU.

Key points:

  • The importer must be established within the EU (not merely commercially active)
  • The concept only applies to devices coming from outside the EU — goods already circulating within the EU do not involve an importer
  • If a manufacturer is itself established in the EU, there is no importer in the supply chain

Importer vs EU REP — what is the difference?​

These roles are distinct and should not be confused:

EU REPImporter
FunctionLegal representative of non-EU manufacturerFirst entity to place the device on the EU market
Must be EU-established?✅✅
Required for all non-EU manufacturers?✅Only if a third-country device is being brought into the EU market
Shares liability with manufacturer?✅ Yes — explicitly✅ For the acts/omissions within their control
Can be same entity?Yes — one company can act as both EU REP and importerYes

In some supply chains, the EU REP and the importer are the same entity. In others, they are separate — for example, the EU REP may be a regulatory consultancy, while the importer is a European distribution company.

Obligations before placing on the market​

Before placing a device on the EU market, the importer must verify:

  1. The device bears the CE marking
  2. An EU Declaration of Conformity (DoC) has been drawn up by the manufacturer
  3. The device has a UDI assigned (where required)
  4. The manufacturer has fulfilled the registration and labelling requirements (including EU REP details on labelling)
  5. The manufacturer has designated an EU REP (for non-EU manufacturers)
  6. The device has been registered in EUDAMED with the required information

If the importer has reason to believe any of these conditions are not met, they must not place the device on the market and must inform the manufacturer, the EU REP, and — where necessary — the competent authority.

caution

An importer cannot simply rely on the manufacturer's word. MDR/IVDR require the importer to carry out their own verification. Placing a non-compliant device on the market makes the importer liable for their own acts or omissions.

Obligations during distribution​

Once a device has been placed on the market, importers must:

  • Ensure that storage and transport conditions while the device is under their responsibility do not jeopardise its conformity with the GSPR (e.g. appropriate temperature, humidity, orientation)
  • Not supply devices that they believe do not conform to MDR/IVDR, or that present a serious risk — and must notify the manufacturer, EU REP, and relevant competent authority
  • Maintain records of complaints and non-conformities and keep the manufacturer and EU REP informed
  • Cooperate with competent authorities on market surveillance and enforcement activities
  • Participate in FSCAs and facilitate recalls when required

Labelling requirements for importers​

The importer's name, registered trade name or trademark, and registered address must be on the device, on its packaging, or in accompanying documentation. Where this would require reopening the packaging, the importer's information may instead be provided on a supplementary label — provided the original labelling remains intact and visible.

tip

Importers should plan for labelling requirements before devices arrive in the EU. Relabelling in the market carries compliance risks and may trigger re-assessment obligations if packaging integrity is affected.

EUDAMED registration​

Importers must register in EUDAMED as an economic operator and receive a Single Registration Number (SRN). This SRN must be used in EUDAMED records linking the importer to the devices they import.

Record-keeping​

Importers must keep records of:

  • Complaints received about devices under their responsibility
  • Non-conformities
  • Recalls and FSCAs

These records must be maintained for the minimum period specified in the regulation (generally 10 years from the last date of placing on the market; 15 years for implantable devices) and made available to competent authorities on request.

When does an importer become a manufacturer?​

A distributor or importer who carries out any of the following becomes a manufacturer and assumes full manufacturer obligations:

  • Placing a device on the market under their own name, trademark, or brand
  • Modifying a device's intended purpose
  • Making changes to a device that affect its conformity with MDR/IVDR (e.g. changing clinical claims, modifying hardware, altering software)
  • Repackaging or relabelling in a way that is not covered by the original DoC

This is a crucial compliance boundary — importers who add their own branding, change labelling claims, or modify devices must reassess their full regulatory obligations as a manufacturer.

Obligations summary​

ObligationMDR reference
Verify CE marking, DoC, UDI, EU REP before importArt. 13(2)
Ensure storage/transport conditionsArt. 13(4)
Register in EUDAMED (SRN)Art. 30
Affix importer name/address to deviceArt. 13(3)
Maintain records of complaints and FSCAsArt. 13(5)
Cooperate with competent authoritiesArt. 13(6)–(7)
Not supply non-compliant devicesArt. 13(8)

Official references​

ReferenceDescription
MDR Art. 2(33)Definition of importer
MDR Art. 13Importer obligations
IVDR Art. 2(30)Definition of importer (IVDR)
IVDR Art. 13Importer obligations (IVDR)
MDCG 2021-17Guidance on economic operators