For a manufacturer established outside the European Union, the EU authorised representative, commonly referred to as the “EC REP”, is a condition of access to the European market. Its role is limited neither to supplying an address to print on the label nor to receiving mail from the authorities.
The authorised representative is a full economic operator. It performs the tasks set out in its mandate, holds responsibilities of its own and may face significant legal liability. The manufacturer must nonetheless remain fully in control of its regulatory obligations: appointing an EC REP does not transfer responsibility for the device’s compliance.
These obligations directly shape our EU authorised representative service under the MDR, from the pre-mandate audit through to vigilance follow-up.
What is an EC REP?
The MDR defines the authorised representative as a natural or legal person established in the European Union who has received and accepted a written mandate from a manufacturer located outside the Union. That mandate authorises it to act on the manufacturer’s behalf for specified tasks relating to the obligations laid down by the regulation.
Three elements therefore characterise this function:
- the authorised representative is established in the European Union;
- its appointment is accepted in writing;
- its tasks and the scope of the devices concerned are defined by a mandate.
Article 11 provides that a non-EU manufacturer’s device may only be placed on the Union market if an authorised representative has been appointed. The appointment must cover at least all devices belonging to the same generic device group. A manufacturer may have several authorised representatives for different generic groups, but should not appoint competing representatives for the same group.
The MDCG 2022-16 guidance devoted to authorised representatives clarifies this arrangement, while recalling that the guidance is a non-legally binding document.
What are the EC REP’s minimum obligations?
Article 11 of the MDR sets out the minimum tasks the mandate must entrust to the authorised representative. The parties may provide for additional services, but they cannot remove the minimum tasks imposed by the regulation.
Verifying that the main regulatory documents exist. The EC REP verifies that the EU declaration of conformity and the technical documentation have been drawn up. Where a notified body must be involved, it also verifies that an appropriate conformity assessment procedure has been applied.
This verification must not be confused with a full approval of the technical file. MDCG 2022-16 interprets it primarily as a check on the existence of the documents and of the applicable assessment procedure.
The authorised representative must nonetheless keep evidence of its checks and be able to demonstrate that it has genuinely performed its tasks. An undocumented statement from the manufacturer may prove insufficient.
Keeping documents available to the authorities. The authorised representative must keep available for the competent authorities an up-to-date copy of:
- the technical documentation;
- the EU declaration of conformity;
- the applicable certificates issued by the notified body;
- the associated amendments and supplements.
These documents must remain available for at least ten years after the last device covered by the EU declaration of conformity has been placed on the market. That period is extended to fifteen years for implantable devices.
The manufacturer must therefore guarantee the authorised representative permanent access to the updated versions.
Meeting and checking certain registration obligations. The authorised representative must meet its own registration obligations as an economic operator. It must also verify that the manufacturer complies with its obligations regarding UDI and device registration in EUDAMED.
It is however inaccurate to claim that the EC REP necessarily creates and manages the manufacturer’s EUDAMED account or that it systematically registers the devices in its place. The non-EU manufacturer submits its own registration application; the selected authorised representative verifies it before it is forwarded to the competent authority. The manufacturer’s obligation to register its information and its devices cannot be transferred to the authorised representative.
Since 28 May 2026, use of the EUDAMED Economic Operators module has been mandatory. A non-EU manufacturer must have an active authorised representative and attach a mandate summary to its registration application. The procedure is set out on the official page for the EUDAMED Actor registration module.
Operational rights or additional tasks may be entrusted to the authorised representative within EUDAMED, depending in particular on the available functionalities and the terms of the mandate. That assistance does not alter the manufacturer’s regulatory responsibility.
Responding to requests from authorities. At the request of a competent authority, the EC REP must provide the information and documents needed to demonstrate the device’s conformity, in an official Union language determined by the Member State concerned.
It also forwards to the manufacturer requests for samples or for access to a device, then verifies that the authority receives the samples or obtains the access requested.
The authorised representative thus constitutes a European point of contact, but it is not the only possible interlocutor. Authorities may also approach the manufacturer, importers, distributors or other economic operators directly.
Cooperating on preventive and corrective measures. The authorised representative cooperates with the competent authorities on any preventive or corrective measure intended to eliminate or reduce the risks posed by devices. That cooperation may involve exchanges with the manufacturer, importers, distributors and the notified body.
It must also immediately inform the manufacturer of complaints and reports received from healthcare professionals, patients or users concerning suspected incidents.
Article 11 does not, however, automatically assign it all of the manufacturer’s vigilance obligations. Responsibilities relating to the vigilance system, the reporting of serious incidents and field safety corrective actions remain attached to the manufacturer. The mandate may organise assistance or the operational submission of certain reports, but that involvement does not transfer the corresponding regulatory responsibility.
Having a PRRC. In accordance with Article 15, the EC REP must have permanently and continuously at its disposal at least one person responsible for regulatory compliance, or PRRC, with the requisite expertise.
This requirement is an important criterion for assessing an authorised representative’s real capabilities. MDCG 2019-07 further states that the PRRC of a non-EU manufacturer and that of its authorised representative cannot be the same person.
What the EC REP cannot take on
Appointing an authorised representative does not relieve the manufacturer of its essential responsibilities. Article 11 in particular prohibits delegating to it several fundamental obligations under Article 10.
The EC REP therefore does not become responsible in the manufacturer’s place for the design of the device, its quality management system, its risk management, its clinical evaluation, the drawing up of the technical documentation, post-market surveillance or production conformity.
Nor can it:
- issue a CE certificate, that task falling to the notified body where one must be involved;
- definitively “validate” the conformity of the technical file;
- guarantee that a device complies with the MDR;
- change the intended purpose, the classification or the regulatory strategy without the manufacturer’s decision and control;
- accept a scope of work contrary to the limits set by the regulation.
The authorised representative may assist the manufacturer in these activities, carry out reviews or flag shortcomings. That contractual assistance does not, however, turn the manufacturer’s non-delegable obligations into obligations of the authorised representative.
How far does the EC REP’s liability extend?
The MDR provides for potentially significant liability, but its scope must be stated precisely.
Under Article 11, where the non-EU manufacturer has failed to meet the obligations laid down in Article 10, the authorised representative may be jointly and severally liable with it for defective devices, on the same basis.
That provision does not mean that the manufacturer and the authorised representative jointly perform all regulatory obligations. According to MDCG 2022-16, triggering this liability presupposes in particular that a device is found defective under the applicable legal regime and that the manufacturer has failed to comply with its obligations under Article 10. The final assessment rests with the competent courts.
This exposure explains why a serious EC REP must assess the manufacturer before accepting the mandate, maintain effective access to the documentation and monitor signals that may reveal non-compliance.
Where the manufacturer fails to meet its obligations, the authorised representative must be able to terminate the mandate. If it terminates on that ground, it must immediately inform its competent authority and, where applicable, the notified body, stating the reasons for its decision.
Why the written mandate is essential
The mandate is the legal and operational foundation of the relationship. It must precisely identify:
- the devices and generic groups covered;
- the minimum tasks under Article 11;
- any additional services;
- the arrangements for access to updated documents;
- the responsibilities relating to EUDAMED;
- the channels for handling complaints and incidents;
- cooperation in the event of a request from an authority;
- the conditions for termination and transition;
- the confidentiality and retention obligations;
- the insurance and liability management arrangements.
The commercial contract and the regulatory mandate may be combined in a single document or organised separately. In either case, their provisions must be consistent.
How to choose your EC REP
The choice should not rest solely on price or on the quick supply of an address. The manufacturer should examine the provider’s regulatory competences, the availability of its PRRC, its review procedures, its ability to handle urgent requests and its insurance cover.
It is also useful to assess its command of EUDAMED, its response times, its document management, its vigilance processes and the arrangements provided for a future termination.
An authorised representative that asks for no information about the devices, the technical documentation, the certificates or the manufacturer’s vigilance system cannot easily demonstrate that it performs the expected checks.
Choosing an authorised representative by default, under time pressure or on price alone can durably weaken the manufacturer’s regulatory control over the European market. An EC REP that lacks competence, availability or involvement risks spotting inconsistencies late, relaying requests from authorities poorly, or failing to escalate signals coming from the market.
The relationship between the manufacturer and its authorised representative should therefore be seen as a genuine regulatory partnership, with no confusion between their respective responsibilities. Where it has the right expertise, procedures and level of involvement, the authorised representative gives the manufacturer a local reading of the European regulatory environment. It is its eyes and ears in the Union: it receives complaints and reports, engages with the authorities and helps escalate the information needed to keep devices under control.
Choosing an unsuitable authorised representative, conversely, weakens that relay. The manufacturer may then identify signals of non-compliance, difficulties encountered by economic operators or expectations expressed by authorities later than it should. That failure does not transfer regulatory responsibility to the authorised representative: above all, it increases the risk that the manufacturer will not have, at the right moment, the information it needs in order to act.
An EC REP should not be chosen as a regulatory address, but as a partner able to see, hear and relay what is happening on the European market.
Key takeaways
The EC REP represents the non-EU manufacturer for specified regulatory tasks, but does not become the manufacturer in its place.
Its main tasks consist of carrying out certain checks, keeping the required documents, meeting its own registration obligations, verifying certain registrations by the manufacturer, cooperating with the authorities and forwarding the complaints and reports it receives.
Its joint and several liability is neither general nor automatic. It concerns defective devices under the conditions laid down in Article 11. That exposure justifies a structured contractual relationship, permanent access to documentation and continuous cooperation with the manufacturer.