Importer Obligations Under EU MDR Article 13

1. Key takeaways

Under Article 13 of the MDR, importers must verify that devices bear the CE marking, are accompanied by the required information and labelled in accordance with the MDR, have been assigned a UDI where applicable, and that the manufacturer and the authorised representative have completed their EUDAMED registration; where an importer considers a device non-compliant, it must not place it on the market and must inform the manufacturer and the authorised representative. Importers must also indicate their name, registered trade name or registered trademark, their registered place of business and a contact address on the device, its packaging or the accompanying documents. The verification duty sits before placing on the market, not after receipt of the goods: if the checks are skipped and the device turns out to be non-compliant, the importer bears the responsibility itself and cannot rely on the manufacturer’s assurances as a defence. In addition, storage and transport conditions must be maintained while the devices are under the importer’s responsibility, and under Article 16 an importer that places devices on the market under its own name, relabels, repackages or translates the accompanying information becomes a manufacturer with the full Article 10 obligations.

2. Legal basis

The importer regime combines pre-market verification duties, labelling duties and handling duties for non-compliant devices.

3. Expert insights

Insight one: the importer’s core action is verification before placing on the market, not paperwork after receipt.

Article 13 places the verification duty before the device is placed on the market: whether the CE marking is affixed, whether the accompanying information is complete, whether the labelling complies with the MDR, whether a UDI has been assigned, and whether the manufacturer and the authorised representative have completed their registrations. If the verification fails and the device is placed on the market anyway, the importer bears responsibility itself and cannot escape liability on the ground that the manufacturer gave assurances. This allocation of duty changes how an import operation should be organised: the checks belong in the release workflow of each batch, executed by a named person and evidenced in writing, not in a supplier questionnaire signed once a year. Where an importer works with many manufacturers, a standard verification checklist applied batch by batch keeps the evidence consistent and retrievable.

Insight two: the importer’s name and address must appear on the device, packaging or accompanying documents.

Article 13 requires the importer to indicate its name, registered trade name or registered trademark, registered place of business and contact address. This is a matter to settle at the labelling design stage, and it is a frequent finding in market surveillance inspections — especially where the importer has changed and the label was not updated in step. Companies importing for multiple markets should manage this as part of labelling change control: when the importer entity changes, the affected labels or accompanying documents must be revised, and devices already placed on the market need a documented decision on how the change is handled downstream.

Insight three: storage and transport conditions are maintained by the importer within its sphere of responsibility.

Under Article 13, the importer must ensure that storage and transport conditions while it is responsible for a device do not compromise its conformity. For temperature-controlled, light-sensitive and pressure-sensitive devices, this means the importer must hold traceable temperature and humidity records and records of how deviations were handled. The practical test an inspector applies is whether the importer can reconstruct the conditions of any given batch, so continuous logging with clear alarm and deviation procedures is the working standard, and the records should be retained for at least as long as the traceability requirements demand.

Insight four: an importer can escalate into a manufacturer.

Under Article 16, an importer that places devices on the market under its own name or trademark, relabels them, repackages them or translates the accompanying information is deemed to be a manufacturer and assumes the Article 10 obligations. This is the compliance turning point most often underestimated in import businesses: commercial teams see a rebranding or a localisation project, while the regulation sees a change of regulatory role that brings design, risk, clinical, documentation and quality management system duties with it.

4. Practical recommendations

1. Establish a pre-market verification checklist covering: CE marking, accompanying information, labelling, UDI, and the EUDAMED registration status of the manufacturer and the authorised representative.
2. File the verification results batch by batch, recording the verifier, the date and the evidence (photographs, screenshots of registration numbers).
3. Include the importer’s information on the label or accompanying documents, and update it in sync whenever the importer changes.
4. For temperature- and humidity-sensitive products, establish records of storage and transport conditions and a deviation handling procedure.
5. Assess whether the business triggers the role change under Article 16; if it does, rebuild the system on the basis of the manufacturer’s obligations.

5. Verification checklist

Review the following items periodically and keep the evidence for each inspection-ready.

• □ A pre-market verification checklist is established and filed batch by batch
• □ CE marking, accompanying information, labelling and UDI have been verified
• □ The EUDAMED registration status of the manufacturer and the authorised representative has been verified
• □ The importer’s name, registered place of business and contact address are indicated (Article 13)
• □ Records of storage and transport conditions are established
• □ Whether the role change under Article 16 is triggered has been assessed

Regulatory information verified as of 29 October 2026.

GRZAN supports importers and manufacturers operating in the European Union market under the EU MDR with appointment as EU Authorised Representative (AR) and Person Responsible for Regulatory Compliance (PRRC), EUDAMED registration support, pre-market verification workflows, and fee and budget planning for notified body conformity assessment under Regulation (EU) 2017/745. Our team helps companies structure their import operations so that Article 13 verification duties, labelling duties and storage conditions are evidenced and inspection-ready, and assesses whether Article 16 role changes apply. For practical support with registration, verification and budget matters, contact GRZAN at info@grzanglobal.com.