If you manufacture medical devices outside the EU, three economic-operator roles stand between you and your EU customers: the Authorised Representative, the importer and the distributor. They are often described interchangeably, sometimes by the companies offering them. Under Regulation (EU) 2017/745 (the MDR) they are distinct, and each carries its own obligations.
The short version
| Authorised Representative | Importer | Distributor | |
|---|---|---|---|
| Who they are | An EU-established person with your written mandate to act on your behalf | The EU-established person that places a device from a third country on the EU market | Any person in the supply chain, other than the manufacturer or importer, that makes a device available |
| Sits in | Legal representation, towards the authorities | The supply chain | The supply chain |
| Needed when | You are established outside the EU (Article 11(1)) | Devices come into the EU from outside it | Devices are sold on within the EU |
| Key MDR article | Article 11 | Article 13 | Article 14 |
The Authorised Representative (Article 11)
A manufacturer not established in a Member State can only place devices on the EU market if it designates a sole Authorised Representative, under a written mandate that the AR accepts. The mandate must allow the AR to perform, at least, the tasks in Article 11(3). In summary, the AR must:
- verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out;
- keep a copy of the technical documentation, the declaration of conformity and any relevant certificates available to competent authorities;
- comply with its own registration obligations and verify that the manufacturer has complied with its registration obligations;
- provide competent authorities, on request, with the information and documentation needed to demonstrate conformity;
- forward authority requests for samples or device access to the manufacturer, and verify the authority receives them;
- cooperate with competent authorities on preventive or corrective action;
- immediately inform the manufacturer about complaints and reports of suspected incidents;
- terminate the mandate if the manufacturer acts contrary to its obligations under the MDR.
Two further points are easy to overlook:
- Liability. Where the manufacturer is not established in a Member State and has not complied with its obligations, the AR is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer (Article 11(5)).
- A person responsible for regulatory compliance (PRRC). Authorised Representatives must have at least one PRRC permanently and continuously at their disposal, with defined qualifications (Article 15(6)).
An AR does not take over the manufacturer’s core responsibilities. Conformity assessment, technical documentation, clinical evaluation and the decision to place a device on the market stay with the manufacturer.
The importer (Article 13)
An importer may only place on the market devices that conform to the MDR. Before doing so it must verify that:
- the device is CE marked and its EU declaration of conformity has been drawn up;
- the manufacturer is identified and has designated an Authorised Representative;
- the device is labelled in accordance with the MDR and accompanied by the required instructions for use;
- where applicable, a UDI has been assigned by the manufacturer.
The importer must also indicate its name, registered trade name or trade mark, registered place of business and contact address on the device, its packaging or an accompanying document; verify that the device is registered in EUDAMED and add its details to the registration; ensure storage and transport conditions don’t compromise the device; keep a register of complaints, non-conforming devices, recalls and withdrawals; forward complaints and suspected-incident reports to the manufacturer and its AR immediately; and keep copies of the declaration of conformity and certificates for the period the MDR requires.
In practice, whoever buys your devices and brings them into the EU is usually the importer, often your EU distributor. An independent importer service is useful when you sell directly to EU customers, have no distributor able or willing to take on the role, or want a single, consistent importer across several distributors.
The distributor (Article 14)
Distributors act with due care. Before making a device available they verify, among other things, that it is CE marked with a declaration of conformity, that it is accompanied by the information the manufacturer must supply, that the importer has met its labelling obligations where applicable, and that a UDI has been assigned where applicable. They also have storage, complaint-handling and cooperation duties.
Can one company hold more than one role?
Yes. Nothing in the MDR prevents the same EU company from acting as both your Authorised Representative and your importer, and many distributors also act as importer. What matters is that each set of obligations is actually fulfilled, and that the roles are documented clearly: in your mandate, your labelling, your declaration of conformity and your EUDAMED data.
It is worth asking any provider offering several roles how they keep the verification duties independent, particularly where the same organisation also provides consultancy on the documentation it is meant to verify.
Where MD QMS SRL fits
MD QMS SRL is registered in EUDAMED and acts as an importer today. Our Authorised Representative service is in development and not yet open for mandates; you can join the launch list. We keep the two roles distinct, and if holding both for your devices would create a conflict, we’ll say so.
This article summarises Articles 11, 13, 14 and 15 of Regulation (EU) 2017/745 as of September 2026 and is not legal advice. Always refer to the current consolidated text.