When a medical device manufacturer established outside the European Union wants to market its products in Europe, several economic operators take part in its regulatory chain. Among them, the importer holds a particular position.
Regulation (EU) 2017/745 (MDR) defines the importer as any natural or legal person established in the Union that places a device from a third country on the Union market.
Its role therefore does not consist simply of arranging transport or customs clearance. By placing a device from a third country on the European market for the first time, the importer becomes an economic operator subject to obligations of its own, mainly set out in Article 13 of the MDR.
For non-EU manufacturers, understanding these responsibilities is essential: the choice and organisation of the importer are an integral part of the European market access strategy and of its durability.
Importer, distributor and authorised representative: three different roles
The first difficulty is to distinguish three actors that non-EU manufacturers still regularly confuse: the EU authorised representative (EC REP), the importer and the distributor. The importer is the actor established in the Union that places a device from a third country on the European market. In other words, it is the first European actor the medical device encounters on its way into the EU market.
To understand the roles of the authorised representative and the distributor, we invite you to consult the corresponding articles in our resources.
These functions are therefore legally distinct, even if, in some configurations, one organisation may combine several roles.
The mandatory checks before placing on the market
Article 13 of the MDR requires the importer to carry out a series of checks before placing a device on the market.
It must in particular verify that:
- the device bears the CE marking and that the EU declaration of conformity has been drawn up;
- the manufacturer is identified and, where it is established outside the Union, that it has appointed an authorised representative in accordance with Article 11;
- 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 cannot therefore simply presume that the manufacturer has completed all the necessary steps: it must carry out its own checks.
This distinction matters: the importer does not perform the conformity assessment in the manufacturer’s place, but it must verify certain elements that establish that the necessary regulatory obligations have been met.
What to do when a device appears non-compliant
The MDR also sets out what to do when the importer considers, or has reason to believe, that a device is not compliant.
In that situation, it must not place the device on the market until its conformity has been restored. It must also inform the manufacturer and its authorised representative.
Where the importer suspects that the device presents a serious risk to patients or users, or that it is a falsified device, it must in addition inform the competent authority of the Member State in which it is established.
This obligation gives the importer a genuine gatekeeping role at the entrance to the European market, in the service of patient and user safety.
An absence of CE marking, a significant inconsistency in the labelling or the absence of the required authorised representative are therefore not mere administrative anomalies that the importer can overlook in order to allow the product to be marketed.
The importer must also be identifiable
The importer is not invisible in the regulatory chain. The MDR requires it to indicate on the device, its packaging or a document accompanying the device:
- its name;
- its registered trade name or registered trade mark;
- the address of its registered place of business at which it can be contacted and located.
This information must be presented in a way that does not obscure the information on the manufacturer’s labelling.
For a non-EU manufacturer, this point must be anticipated early enough. The choice of importer can have very concrete consequences for the packaging and the product’s documentary organisation.
Appointing an importer does not replace appointing an EU authorised representative: for a non-EU manufacturer, the two roles coexist.
EUDAMED: what obligations for the importer?
The mandatory application of several EUDAMED modules since 28 May 2026 makes this question even more important.
The importer is among the economic operators covered by the registration requirements applicable in EUDAMED.
But two things must be distinguished: the registration of the importer as an actor and the registration of the device itself. The manufacturer remains responsible for registering its devices in accordance with the applicable provisions of the MDR.
For its part, the importer verifies that the device is registered in the electronic system in accordance with the applicable requirements and adds its own information to the relevant registration. EUDAMED then establishes the link between the manufacturer and the importer.
Traceability: what the importer must actually keep
Traceability is another important responsibility.
Article 25 of the MDR requires economic operators to be able to identify, for the period referred to in Article 10, the economic operators to whom they have directly supplied a device, those who have directly supplied them with one, and certain health institutions or healthcare professionals to whom they have directly supplied a device.
The reference period referred to in Article 10 is 10 years after the last device covered by the EU declaration of conformity has been placed on the market, and 15 years for implantable devices.
This duration must therefore be taken into account in the documentary organisation and traceability systems of the economic operators concerned.
Complaints, non-conformities and vigilance
The importer’s role does not stop when the product is sold. It must also monitor the products it has placed on the market. Thus, when it receives complaints or reports from healthcare professionals, patients or users concerning suspected incidents relating to a device it has placed on the market, it must immediately forward that information to the manufacturer and its authorised representative.
It must also keep a register of:
- complaints;
- non-conforming devices;
- recalls;
- withdrawals.
And it provides the manufacturer, the authorised representative and the distributors with any information they request to enable them to investigate complaints (Article 13(6)).
The importer thus becomes an essential source of post-market information for the manufacturer. For a manufacturer located several thousand kilometres from the European market, this function is particularly important: the first information about a problem encountered in the field may reach the importer before it reaches the manufacturer’s regulatory team.
Storage and transport: an often underestimated responsibility
The MDR also requires the importer to ensure that, while a device is under its responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements. This obligation is particularly important for devices subject to specific temperature, humidity or handling conditions. The importer must therefore have an organisation consistent with the characteristics of the devices it handles. Perfect compliance as the product leaves the factory is not enough if storage or transport conditions subsequently compromise the product’s performance or safety.
Cooperating with the competent authorities
The importer is also directly exposed to requests from European authorities. At the request of a competent authority, it must in particular provide the information and documents in its possession that are needed to demonstrate the device’s conformity. It must also cooperate in actions intended to eliminate or, where that is not possible, reduce the risks posed by the devices it has placed on the market. That cooperation may extend to providing free samples or, where this is not feasible, access to the device. The importer must therefore be able to respond rapidly to a regulatory request and to communicate effectively with the manufacturer and its authorised representative.
What this means in practice for the importer’s organisation
To meet its MDR obligations, the importer must turn regulatory requirements into operational processes.
It should in particular have a documented process allowing it to:
1. Qualify the manufacturers and devices imported. Before first placing on the market, the necessary regulatory elements must be verified.
2. Carry out the checks provided for in Article 13. The check must be sufficiently documented to allow it to be demonstrated that it was genuinely performed.
3. Master the EUDAMED information. The respective responsibilities of the manufacturer, the authorised representative and the importer must be clearly defined.
4. Ensure traceability. The company must be able to identify device flows and the operators concerned for the applicable regulatory periods.
5. Handle complaints and non-conformities. A procedure must allow the relevant information to be received, recorded and quickly forwarded to the manufacturer and the authorised representative.
6. Manage storage and transport conditions. Where the characteristics of the device require it, environmental conditions must be controlled and documented.
7. Respond to the authorities. Internal responsibilities and escalation channels must be defined before an urgent request arises.
The importer is not just a logistics provider
This is probably the most significant mistake for a non-EU manufacturer. A company can be perfectly capable of transporting, storing, clearing and delivering products without having the regulatory organisation needed to properly perform the role of importer within the meaning of the MDR.
Conversely, a company contractually designated as a “distributor” may, depending on the reality of the commercial flows and of the placing on the market, find itself in a situation that requires its status under the regulation to be analysed.
The qualification of economic operators must therefore be based on their actual role in the placing-on-the-market chain, and not solely on the title appearing in a commercial contract.
When the importer may be considered a manufacturer
The importer must also take care not to cross the line between its role and that of the manufacturer. In certain situations, the manufacturer’s obligations may indeed apply directly to the importer. Article 16 of the MDR provides for this in particular where an importer makes a device available on the market under its own name, its own company name or its own trade mark — unless there is a specific agreement with the manufacturer allowing the latter to remain identified as such and responsible for the applicable requirements — or where it modifies a device already placed on the market in a way liable to affect its compliance with the MDR. The consequences are significant: the importer concerned no longer bears only the obligations under Article 13 but assumes the obligations incumbent on the manufacturer.
Certain operations, such as translating the information supplied by the manufacturer or certain packaging changes needed for marketing in a Member State, nonetheless benefit from a specific regime and do not automatically lead to that reclassification, subject to compliance with the conditions set out in Article 16. For the importer, any change to the product, its labelling, its packaging or the way it is marketed must therefore be the subject of a prior regulatory analysis.
Key takeaways
Under the MDR, the importer is far more than a commercial or logistics intermediary. It constitutes one of the regulatory checkpoints between the non-EU manufacturer and the European market. Before placing on the market, it must verify several essential elements of compliance; afterwards, it must meet its identification and traceability obligations, handle and forward information about complaints and non-conformities, control storage and transport conditions and cooperate with the competent authorities.
For a non-EU manufacturer, the choice of an importer should therefore never rest solely on the cost of transport, storage or customs clearance. Its ability to understand and perform the responsibilities set out in Article 13 of the MDR is just as decisive in securing durable access to the European market.