MDR Economic Operators: The Duties Importers and Distributors Can't Delegate Upstream

A CE mark tells an importer or distributor that a manufacturer has done its job. It does not tell a competent authority that the importer or distributor has done theirs. Under MDR Articles 13 and 14, importers and distributors carry independent verification and record-keeping duties that a manufacturer's diligence does not discharge and a supply contract cannot delegate away. Most EU device programs have this mapped for the manufacturer role. Fewer have it mapped for every other economic operator actually moving the device to market.

What Article 13 actually requires of importers

Before placing a device on the EU market, an importer must verify that the CE mark and EU Declaration of Conformity exist, that the manufacturer is identified and has appointed an authorised representative where required, and that the device is labelled and accompanied by instructions in line with the Regulation. That verification is a duty, not a formality — while the device is under the importer's responsibility, storage and transport conditions must not jeopardise its compliance with Annex I's general safety and performance requirements, and must follow the manufacturer's conditions where the manufacturer has specified them. The importer's own name, registered trade name, and contact address must also appear on the device, its packaging, or an accompanying document.

Distributors verify too — they don't just re-check the importer's paperwork

Article 14 puts a parallel, independent duty on distributors: before making a device available, confirm the CE mark and labelling are present, and that the manufacturer — and, where applicable, the importer — are correctly identified on the device or its packaging. MDCG 2021-27 is explicit that physical checks matter: a distributor cannot satisfy the obligation with a documentation review alone unless a physical check would compromise the device's packaging or condition. Outsourcing the verification to a subcontractor does not relieve the distributor of the legal duty — it still has to be able to demonstrate to a competent authority that the check happened.

• Importers verify CE marking, DoC, authorised-representative appointment, labelling, and storage/transport conditions, and put their own identity on the device or its packaging.
• Distributors verify CE marking, labelling, and that upstream identification requirements were met — independently, not by reference to the importer's paperwork.
• Both keep a register of complaints, non-conforming devices, and recalls or withdrawals, and share it with the manufacturer, authorised representative, and each other on request.
• Neither can transfer these duties to the other by contract — the obligation sits with whichever party is legally acting in that role for that market.

A distributor that relies on the importer's compliance check has not performed its own — and the Regulation asks each economic operator for its own. Why verification duties don't pass through the supply chain

When relabelling or repackaging makes you the manufacturer's problem

Article 16 is where economic-operator obligations get expensive to misjudge. A distributor or importer that translates the label or instructions for use, or repackages the device, generally takes on the obligations the Regulation otherwise reserves for manufacturers — unless narrow conditions are met on how the activity is performed and communicated. That means a quality management system covering translation accuracy and packaging integrity, own-identity marking on the relabelled device, and — at least 28 days before the relabelled or repackaged device reaches the market — notice to the manufacturer and the competent authority, along with, on request, a sample and a notified body certificate attesting to that QMS. Companies that treat relabelling as a logistics task rather than a regulatory one are the ones who discover the 28-day clock only after it has already started running against them.

The pattern behind most gaps here isn't bad faith — it's a supply chain built around CE marking as the single compliance event, with verification, storage, and complaint duties assumed to travel downstream with the device automatically. They don't. Each economic operator's due diligence is its own legal obligation, tested independently by whichever competent authority is asking, and it sits alongside — not underneath — the manufacturer's registration and reporting obligations we've covered in our EUDAMED registration timeline. If your last review of the importer and distributor chain was a contract read rather than a verification-record audit, that is the gap to close first.