An importer answers for the device after the sale

Two economic-operator duty lists already have a place on this blog: the authorised representative's mandate under MDR Article 11, and the distributor's four-item check under Article 14. Article 13 governs a third actor in the same supply chain, and its list runs longer than either of the other two. An importer isn't a distributor with an extra customs form — it verifies one more thing at intake than a distributor does, has to put its own name on the device, and carries duties that don't stop when the sale closes.

A four-item check, with one item the distributor's list skips

Article 13(2) requires an importer, before placing a device on the market, to verify that: the device carries the CE mark and its EU declaration of conformity has been drawn up; a manufacturer is identified and has designated an authorised representative in accordance with Article 11; the device is labelled in accordance with the Regulation and accompanied by the required instructions for use; and, where applicable, a UDI has been assigned by the manufacturer under Article 27. A distributor's own four-item check under Article 14(2) covers similar ground, but its second item asks something different — that the device is accompanied by the information the manufacturer owes it under Article 10(11), not that a manufacturer and an authorised representative are actually identified. That's the item the importer's list carries and the distributor's doesn't: by the time a device reaches a distributor, an importer somewhere upstream has already confirmed the manufacturer-and-representative link the rest of the chain takes for granted.

The importer's own name has to reach the device

Article 13(3) adds a duty no distributor carries: the importer has to indicate its own name, registered trade name or trade mark, registered place of business, and a contactable address, on the device itself, on its packaging, or in an accompanying document — without obscuring any label information the manufacturer put there first. A distributor verifies that a label is compliant. An importer has to become part of it. A compliance file that treats this as a customs or logistics detail, handled outside the regulatory record, is missing a labelling obligation the Regulation assigns to the importer by name.

A registration duty layered on top of the checklist

Article 13(4) requires the importer to verify that the device is registered in the electronic system — EUDAMED — in accordance with Article 29, and to add its own details to that registration under Article 31, the same provision that assigns every manufacturer, authorised representative, and importer a Single Registration Number. A UDI has to resurface correctly at several points after it leaves the label; the importer's registration check is one more of those points, and it's a duty a distributor's own four-item list never asks it to perform.

Custody, complaints, and a retention clock that outlasts the sale

Article 13(5) ties a further duty to physical custody specifically: while a device is under the importer's responsibility, storage and transport conditions can't jeopardise its compliance with the general safety and performance requirements in Annex I, and the importer has to follow any conditions the manufacturer has specified. Article 13(6) requires a register of complaints, non-conforming devices, and recalls or withdrawals, shared with the manufacturer, authorised representative, and distributors on request. Two separate triggers then require the importer to act: under Article 13(7), an importer that considers or has reason to believe a device it placed on the market isn't in conformity has to inform the manufacturer and its authorised representative immediately; under Article 13(8), an importer that receives a complaint or an incident report from a healthcare professional, patient, or user has to forward it immediately, regardless of whether the importer independently shares the concern. And Article 13(9) keeps the file open long after the transaction closes — a copy of the declaration of conformity and any relevant certificate has to be retained for the period Article 10(8) sets for the manufacturer itself: at least ten years after the last device covered by that declaration is placed on the market, or fifteen for an implantable device.

Where this meets the rest of the file

Article 13, Article 14, and Article 11's authorised-representative mandate divide one supply chain's compliance obligations across three actors with three different duty lists, not one general standard of care applied three times under different headings. An importer compliance log built around Article 13's actual sequence — the four-item check, the self-identification duty, the registration step, and the retention clock that runs past the sale — is previewed in the launch catalog. If your program tracks importer obligations differently, the shelf takes that correction directly.