Economic Operators under EU MDR: Manufacturer, Representative, Importer, Distributor

1. Key takeaways

The MDR distributes responsibility across four categories of economic operators: the manufacturer (Article 10), the European authorised representative (Article 11), the importer (Article 13) and the distributor (Article 14). The intensity of the obligations decreases in that order, and the roles can be cumulative: the same company may carry two roles on the same device. For any manufacturer outside the European Union, the practical questions are which role it holds, which roles its European partners hold, and how the written arrangements between them capture the duties the Regulation assigns to each. A supply chain map that does not answer those three questions leaves obligations unassigned, and unassigned obligations are the ones that surface as non-conformities during audits and inspections.

2. Legal basis

3. Expert insights

Insight 1: The manufacturer definition looks at in whose name the device is placed on the market, not at who physically makes it.

Under Article 2(33), a manufacturer is any natural or legal person who manufactures or fully refurbishes a device, or has a device designed, manufactured or fully refurbished, and markets that device under its own name or trademark. The contract manufacturer is therefore not the manufacturer; the commissioning party is. A brand owner that never touches a production line is still the manufacturer under the MDR and bears the full set of Article 10 obligations, from risk management to vigilance. This allocation follows the name on the label, and it cannot be shifted to the factory by contract. Outsourcing agreements should be drafted with this allocation in mind rather than assuming the factory inherits regulatory duties.

Insight 2: An authorised representative is mandatory only when the manufacturer is not established in the EU, and it is a sole appointment.

Under Article 11(1), where the manufacturer is not established in a Member State, its devices may be placed on the EU market only if the manufacturer has designated a sole authorised representative. Under Article 11(2), the designation constitutes the mandate of the authorised representative and is valid only once the authorised representative has accepted it in writing, and it must cover all devices of the same generic device group. The consequence for non-EU manufacturers is that they cannot appoint several representatives per product line to hedge dependence, and that the mandate letter needs review for scope, acceptance and termination mechanics before it is signed, since a defective mandate can undermine registration and vigilance duties that depend on the representative.

Insight 3: The dividing line between importer and distributor is whether the company places devices from a third country on the EU market.

Under Article 2(34), an importer is a person established in the Union who places devices from a third country on the Union market. A distributor is any person in the supply chain, other than the manufacturer and the importer, who makes a device available on the market up until it is put into service. An EU company that buys from another EU company within the Union and resells is a distributor; a company that imports directly from China, the Chinese mainland, or any third country and places the devices on the EU market is an importer. The distinction is decisive because the importer duties include verification before placing on the market and registration, while distributor duties centre on operational checks and reporting along the chain.

Insight 4: Roles can stack, and the obligations accumulate when they do.

Under Article 16, an importer or distributor that places a device on the market under its own name or trademark, relabels it, repackages it, or translates the instructions for use is deemed to be a manufacturer and assumes the obligations of Article 10. In addition, a single EU company can be the importer of one product and the distributor of another, with both sets of duties running in parallel. Companies should therefore map roles per product, not per company, and monitor which commercial activities, especially relabelling and translation, shift them into the manufacturer role with its full documentary and quality management consequences.

4. Practical recommendations

1. Draw a role matrix: annotate every cell of SKU × operator with the role held, so that no operator carries a confused role across different products.
2. When signing the written mandate with the authorised representative, compare it item by item with the task list of Article 11(3) and make the non-delegable matters of Article 11(4) explicit.
3. Importers should build a pre-placing verification checklist covering the CE marking, accompanying information, labelling, UDI and EUDAMED registration status.
4. Distributors should maintain a list of triggers for refusing to make a device available, and keep records of notifications to the manufacturer and the authorised representative.
5. Any business involving relabelling, repackaging or translation should be assessed first for whether it triggers a role change under Article 16.

5. Verification checklist

• □ The role of each operator (manufacturer, authorised representative, importer, distributor) has been determined per SKU
• □ It is confirmed that the non-EU manufacturer has designated a sole authorised representative (Article 11(1))
• □ The mandate has been accepted in writing and covers the same generic device group (Article 11(2))
• □ The importer has completed the pre-placing verification checklist
• □ The distributor has established a notification process for non-compliant devices
• □ Any business triggering a role change under Article 16 has been assessed

Regulatory information verified as of 29 October 2026.

About GRZAN. GRZAN structures the economic operator framework for manufacturers entering the European Union under Regulation (EU) 2017/745. We map roles across your SKU portfolio, draft and review authorised representative mandates, build importer and distributor verification procedures, and keep the whole chain aligned with the obligations of Articles 10 to 16 on the path to CE marking in the EU MDR market. From role mapping to audit-ready documentation, GRZAN is your compliance partner for the European Union. Contact info@grzanglobal.com.