Economic Operators Under EU MDR: Manufacturer, Authorised Representative, Importer, and Distributor

Why the economic operator framework matters

Under MDR, responsibility for a medical device does not rest solely with whoever made it. The regulation assigns specific obligations to every organisation that handles the device in the supply chain — manufacturers, authorised representatives, importers, and distributors. The idea is that every link in the chain bears a proportionate level of accountability, so that if something goes wrong, there is always a responsible party with clear legal obligations in the EU.

In practice, this matters because the obligations are real and the exposure is too. A distributor who discovers a device is non-compliant and continues to supply it has its own liability. An importer who fails to check that a non-EU manufacturer has an authorised representative can face market surveillance action. Understanding where your organisation sits — and what that means — is not just a compliance formality.

The manufacturer

The manufacturer bears the primary compliance burden. Under MDR, the manufacturer is the organisation that designs, manufactures, labels, and places a device on the market under its own name — or that has a device designed and manufactured by another organisation but places it on the market under its own name (as a private label manufacturer). Both scenarios give you the full manufacturer obligations.

Those obligations include: performing the conformity assessment, signing the Declaration of Conformity, maintaining the Quality Management System, conducting post-market surveillance, reporting serious incidents, registering in EUDAMED, assigning and labelling UDIs, and keeping technical documentation current. This is the full weight of MDR compliance.

One thing worth noting: if you commission manufacturing from a contract manufacturer but put your name and CE mark on the product, you are the manufacturer for MDR purposes. The contract manufacturer's obligations are governed by your agreement with them, not by MDR directly. If the contract manufacturer also places the same product on the market under their own name, they too are a manufacturer and carry their own obligations.

The Authorised Representative

Non-EU manufacturers that want to place devices on the EU market must designate an Authorised Representative (AR) established in the EU. The AR is the legal contact point for EU regulatory authorities. Under MDR, the AR's obligations are more substantial than they were under MDD.

The AR must register the manufacturer and its devices in EUDAMED, keep a copy of the Declaration of Conformity and technical documentation (or be able to access it immediately), and cooperate with competent authorities on post-market surveillance and vigilance. Critically, the AR can be held liable for non-compliant devices placed on the EU market under its mandate. This is a change from MDD, where AR liability was more limited. The practical consequence is that serious ARs now conduct meaningful due diligence on manufacturers before accepting mandates — and they can and do terminate mandates for manufacturers who fail to meet their obligations.

If you are a non-EU manufacturer and you do not have an AR, your device cannot legally be placed on the EU market. Getting this in place early — and choosing an AR that actually has the capacity to fulfil its obligations — is a prerequisite, not an afterthought.

The importer

An importer is an EU-established organisation that places a device from a non-EU manufacturer on the EU market. If you are purchasing devices manufactured outside the EU and selling them in the EU under the manufacturer's name and CE mark, you are an importer under MDR.

Importers must verify that the manufacturer has appointed an AR, that the device carries a CE mark and has a DoC, that the device is correctly labelled with the required information, and that the manufacturer has registered in EUDAMED. They must also ensure that the manufacturer reports serious incidents, keep a register of complaints, non-conforming devices, and recalls, and cooperate with competent authorities. Importantly, importers must register themselves in EUDAMED and their contact details must appear on the device label or its packaging.

This is where a lot of organisations get caught out: a company that buys a device from a non-EU manufacturer and resells it in the EU thinks of itself purely as a distributor — but if it is the first party placing the device on the EU market, it is an importer with significantly heavier obligations.

The distributor

A distributor is an organisation that makes a device available on the EU market — after it has already been placed on the market — but is not the manufacturer or importer. Distributors have lighter obligations than importers, but they are not obligation-free.

Distributors must verify that the device carries a CE mark, has a DoC, is correctly labelled, and has not reached its expiry date. They must maintain records of devices they have supplied sufficient to enable traceability. They must cooperate with competent authority investigations and report serious incidents they become aware of to the manufacturer and competent authority.

The boundary between importer and distributor is sometimes blurry for companies operating across EU and non-EU markets. If you are in multiple roles — buying some devices from EU manufacturers and some from non-EU manufacturers — your obligations differ by product line. The safest approach is to map your supply chain specifically, by product, and assign the correct role explicitly.

When roles overlap and cause problems

The economic operator framework creates friction when roles are unclear or when organisations try to minimise their obligations by characterising their role as something lighter than it actually is. A common scenario: a company in the EU imports devices from a manufacturer in Asia, adds some packaging and a translated IFU, and argues it is a distributor rather than a manufacturer. Whether this is correct depends on the extent of the changes — adding a translated IFU alone may not change your role, but repackaging or relabelling in a way that could affect conformity may make you a manufacturer. Article 16 of MDR addresses this and sets out when a distributor or importer becomes a manufacturer by virtue of the changes they make. Reading it carefully against your actual activities is worth doing.