MDR and IVDR · Articles 11–13 · EU market entry
Authorised representative and importer
Two EU addresses. Two legal roles. One device that must not fall between them.
A non-EU manufacturer appoints one role by written mandate. A supply transaction creates the other. Both stand inside the Union, but they guard different doors of the regulatory system.
Follow the device ↓Owns the device and its compliance
Regulatory interface
Market-entry checkpoint
release only when compliant
The essential distinction
They may share an office. They do not share a job.
The authorised representative exists because the manufacturer is outside the Union. The importer exists because an individual device is being placed on the Union market from a third country.
One role is created by designation. The other follows the supply chain. Treating them as interchangeable creates gaps exactly where regulators expect a clear line of control.
01
The device crosses two regulatory lines #
Imagine a device leaving a factory outside the EU. Before it can be placed on the Union market, the manufacturer must already have a sole authorised representative for the covered generic device group. When an EU-based business obtains that device from outside the Union and performs its first making available, that business acts as the importer.
The two roles answer different questions. Who is the manufacturer's regulatory contact inside the Union? That is the authorised representative. Who placed this individual device on the Union market? That is the importer.
A written mandate is offered and accepted for specified tasks and at least one complete generic device group.
authorised representativeThe role follows the legal supply transaction for the individual device, not a ceremonial appointment.
importerDo not decide the role from the company name, warehouse location or invoice label alone. Trace who obtained the individual device from outside the Union and who first made it available there.
02
The authorised representative is a regulatory interface, not a rented address #
Article 11 gives the authorised representative a minimum operating brief. The representative verifies that core conformity records exist, keeps defined documents available, supports registration, responds to authorities, passes on complaints and cooperates with preventive or corrective action.
The manufacturer must enable performance, not merely describe it.
Declaration, technical documentation and the applicable conformity procedure
Technical documentation, declaration and relevant certificate copies
Own registration duties and manufacturer or device verification
Information, documentation, samples and access in the required language
Complaints and suspected-incident reports reach the manufacturer immediately
Preventive and corrective action is supported through to execution
The mandate cannot become a shield for a manufacturer acting contrary to the Regulations
Persistent manufacturer noncompliance can trigger termination and regulatory notification
The mandate has a boundary
The manufacturer remains the manufacturer. Core Article 10 obligations cannot be delegated away through the mandate. The representative may assist, scrutinise and coordinate, but cannot become the legal author of compliance simply because the manufacturer is geographically distant.
The role also carries real exposure. Where a non-EU manufacturer has not complied with its Article 10 obligations, Article 11 provides for the authorised representative to be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
03
The importer controls the market-entry gate #
The importer does not repeat the notified body's conformity assessment. It performs defined verification before placing the device on the market. A failed check is not an administrative inconvenience. It is a stop signal.
Confirm CE marking and that the EU declaration of conformity has been drawn up.
verifyIdentify the manufacturer and verify the Article 11 designation where required.
verifyConfirm that the device carries the required information and instructions.
verifyCheck that the manufacturer has assigned the required identifier.
verifyMarket placement may proceed
releaseThe job continues after release
The importer adds its own identity and contact address without obscuring manufacturer information. It protects the device during storage and transport, keeps complaint and corrective-action records, retains copies of the declaration and relevant certificates, forwards suspected-incident reports, and cooperates with manufacturers, representatives and authorities.
Importer status attaches to the individual device and its first making available. Different importers may place different units of the same model on the Union market, but the same individual device cannot have several first importers.
04
Put the roles side by side and the confusion disappears #
The fastest way to design the operating model is to compare the legal trigger, object of control and evidence expected from each role.
The manufacturer is not established in the Union.
A device from a third country is first placed on the Union market.
A written mandate accepted by the representative.
The actual supply-chain transaction and market placement.
Specified tasks for at least all devices in the same generic device group.
The individual devices placed on the market by that importer.
Regulatory representation, document availability and authority cooperation.
Pre-placement verification, identity, logistics and market feedback.
Only one per specific generic device group, although different groups may use different representatives.
Several may exist for the same model when each imports different individual devices.
No. Non-delegable manufacturer duties remain with the manufacturer.
No. Verification does not transfer product compliance ownership.
05
A resilient system moves records in both directions #
Market access sends evidence toward the Union. Post-market experience sends signals back to the manufacturer. The representative and importer sit at different junctions in that loop, so contracts, procedures and system permissions must match the legal route.
Declaration, technical documentation and certificate status
Mandate scope, registrations, labels and contact routes
Products, batches, territories, dates and responsible importer
Complaints, suspected incidents, nonconformities, recalls and withdrawals
Documents, translations, samples, access and corrective action
Certificate, label, UDI, product and operator changes reach every checkpoint
A PDF stored somewhere in the group is not a control. Each operator needs defined access, review frequency, escalation time, retention period and evidence that the current version reached the point where the legal check is performed.
06
When a check fails, the device waits #
An importer that has reason to believe a device is nonconforming must not place it on the market until conformity is restored. A representative that discovers manufacturer noncompliance must use its mandate, cooperate on correction and ultimately terminate if the manufacturer continues to act contrary to the Regulations.
Record the device, evidence, affected units and immediate risk.
Preserve stock and prevent further making available where required.
Manufacturer, representative, importer and distributors coordinate facts and action.
Serious risk or falsification activates competent-authority and, where applicable, notified-body routes.
Close the action only when execution and effectiveness are documented.
07
One company may wear both badges, but must run both controls #
The same legal person can act as authorised representative and importer for a specific device. That does not fuse Articles 11 and 13 into one general service. The company must be able to demonstrate compliance with both sets of obligations.
Scope review · regulatory verification · authority interface · mandate escalation
Shipment verification · importer identification · logistics · placement records
Commercial convenience can create a hidden conflict. The same company may be paid to move the device quickly and expected to block it when evidence is incomplete. Procedures must give the regulatory decision enough independence, authority and documented escalation to withstand that pressure.
08
Changing representative is a controlled handover, not a new logo #
Article 12 requires detailed arrangements between the manufacturer, the incoming representative and, where practicable, the outgoing representative. A defensible transfer closes the old mandate without interrupting document access, complaint routing or regulator contact.
Define the end of the outgoing mandate and start of the incoming mandate.
Set how long the outgoing representative may appear on labels and promotional material.
Address access, completeness, confidentiality and property rights.
Ensure post-termination complaints and suspected incidents reach the correct party.
At every point in the transfer, an authority should be able to identify the responsible representative, obtain the required documents and route a safety signal without guessing.
09
Build the operating model before the first shipment #
The legal text names duties. The operating model makes them happen on Tuesday afternoon when a certificate changes, a shipment arrives and a complaint lands in a different inbox.
- Map every non-EU manufacturer, generic device group and Union supply route
- Identify the authorised representative and importer for each relevant scenario
- Align the written mandate, quality agreement and commercial contracts without blurring legal roles
- Translate every Article 11 and Article 13 duty into a procedure, owner, record and deadline
- Build pre-placement checklists around actual devices and shipments
- Connect complaint, vigilance, recall and authority-request routes across all operators
- Audit document access, label control, registration data and storage conditions
- Rehearse the moment when a device must be stopped
Official sources
- Regulation (EU) 2017/745 on medical devices
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- MDCG 2022-16 guidance on authorised representatives
- MDCG 2021-27 Rev.1 questions and answers on importers and distributors
- European Commission guidance index for authorised representatives, importers and distributors
The regulatory outcome
A clear handoff is part of product compliance
The authorised representative connects a non-EU manufacturer to the Union regulatory system. The importer controls the first market placement of devices arriving from a third country. Neither role replaces the manufacturer, and neither can operate as an address-only formality.
The strongest model makes every handoff visible. It identifies who checks, who records, who stops, who informs and who can prove that the action happened.
Different trigger. Different control. One uninterrupted line of accountability.
EU market-entry architecture
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