EU representation · written mandate · regulatory interface
The EU Authorised Representative mandate
More than a commercial contract
For a manufacturer established outside the European Union, the mandate defines a regulated relationship. It gives the representative specific duties, preserves the manufacturer’s own obligations and creates a formal interface with EU authorities.
Open the mandate architecture ↓Product responsibility
Defined devices · defined tasks
Regulatory interface
The central distinction
The mandate assigns tasks, not the manufacturer’s legal identity
The Authorised Representative takes on the duties expressly allocated by Article 11 and by the written mandate. The manufacturer remains responsible for the device, its conformity and the regulatory system behind it.
01
Why the written mandate is required #
A manufacturer that is not established in an EU Member State may place a device on the Union market only after designating a sole Authorised Representative. This requirement appears in Article 11 of both the MDR and the IVDR.
The designation is not created by adding an EC REP symbol to a label or by exchanging ordinary commercial terms. It constitutes a mandate and becomes valid only when the Authorised Representative accepts it in writing.
The mandate is therefore the legal foundation of the relationship. It identifies the parties, the devices covered and the tasks the representative accepts. A competent authority may require evidence of that relationship and may interact directly with the representative concerning the covered devices.
No written acceptance means no valid designation. No clearly defined scope means uncertainty about which devices and duties the representative has accepted.
The legal text can be reviewed in MDR Article 11 and IVDR Article 11. The European Commission’s MDCG 2022-16 guidance provides additional interpretation.
02
Who may act as an Authorised Representative #
The MDR and IVDR define an Authorised Representative as a natural or legal person established within the Union that has received and accepted a written mandate from a manufacturer located outside the Union.
This means that the representative does not necessarily have to be a company. It must, however, be genuinely established in the EU and capable of performing the regulatory duties it accepts.
The representative is more than a postal address. It must maintain the competence, availability, procedures and document access needed to communicate with manufacturers and authorities, assess whether specified regulatory steps have been completed and act when a safety or compliance problem arises.
For an overview of the role, see the MDRC pages on the EU Authorised Representative service and the difference between an Authorised Representative and an importer.
03
How the designation and device scope should be defined #
The mandate should leave no doubt about the devices it covers. The Regulations require the mandate to be effective at least for all devices belonging to the same generic device group.
A manufacturer may use different Authorised Representatives for different generic device groups, but it cannot split one generic device group between several representatives. For each covered group, there must be one sole Authorised Representative.
A practical device schedule may identify trade names, models, catalogue numbers, Basic UDI-DIs, risk classes, applicable regulation and certificate references. It should also establish how new devices, variants or groups are added and when the representative must approve an amendment to the scope.
04
The mandatory duties belong in the mandate #
Article 11 defines a minimum set of tasks. The wording of the contract may be adapted to the parties’ operating model, but the substance of these duties cannot be removed.
- 01
Verify the conformity framework
Verify that the EU Declaration of Conformity and technical documentation have been drawn up and that the required conformity assessment procedure has been completed.
- 02
Retain regulatory records
Keep copies of the technical documentation, Declaration of Conformity and relevant certificates, including amendments and supplements, available to competent authorities for the required retention period.
- 03
Address registration obligations
Complete the representative’s own actor-registration obligations and verify that the manufacturer has fulfilled the applicable UDI and device-registration obligations.
- 04
Respond to authority requests
Provide competent authorities with the information and documentation needed to demonstrate device conformity, in the language required by the relevant Member State.
- 05
Support access to devices
Forward authority requests for samples or access to a device and verify that the authority receives the requested samples or access.
- 06
Cooperate on regulatory action
Cooperate with competent authorities on preventive or corrective action taken to eliminate or mitigate device risks.
- 07
Forward safety information
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients or users concerning suspected incidents related to a covered device.
- 08
Act on manufacturer non-compliance
Terminate the legal relationship if the manufacturer acts contrary to its obligations under the applicable Regulation, and notify the relevant authority and Notified Body where required.
The representative verifies that specified regulatory outputs exist and retains access to them. It does not become the author of the technical documentation or the manufacturer of the device merely by carrying out those checks.
The regulatory boundary
What the mandate allocates—and what it cannot transfer
An Authorised Representative takes responsibility for its own Article 11 duties. The manufacturer remains the legal manufacturer and retains the obligations that Article 11 expressly prevents it from delegating.
Regulatory interface and verification
- Written acceptance of the mandate
- Verification of defined regulatory outputs
- Document retention and authority access
- Own actor registration and manufacturer checks
- Authority communication and cooperation
- Complaint and incident-information forwarding
- Action when the manufacturer is non-compliant
Device conformity and lifecycle control
- Device design and manufacture
- Risk management
- Clinical or performance evaluation
- Technical documentation
- Quality management system
- Post-market surveillance and vigilance
- Corrective action and continuing conformity
The representative may provide separate administrative or consulting support, but the agreement must not suggest that the manufacturer’s statutory responsibility has been transferred.
06
Additional services may be agreed separately #
The parties may agree that the Authorised Representative will perform work beyond the minimum Article 11 duties. This may include administrative support for national registrations, applications for Certificates of Free Sale, coordination with authorities, regulatory correspondence and practical assistance with EUDAMED.
The distinction between support and legal responsibility should remain visible. For example, a representative may help transmit a vigilance report or coordinate a corrective action, but the manufacturer still owns the vigilance system, the underlying assessment and the regulatory decision.
The same applies to post-market surveillance. Operational support may be valuable, particularly where complaints or authority communications arise in several Member States. It does not relocate responsibility for the manufacturer’s post-market surveillance system.
If the representative also supplies regulatory consulting, the contract should distinguish the Article 11 mandate from any separate advisory work and avoid language that confuses assistance with delegation.
07
The representative must have access to a qualified PRRC #
An Authorised Representative must have permanently and continuously at its disposal at least one Person Responsible for Regulatory Compliance with the expertise required for medical devices or IVDs.
The legal wording does not simply require “someone experienced.” The individual must satisfy the qualification and experience criteria applicable under Article 15. Where the PRRC is external, the arrangement must still provide permanent and continuous availability rather than occasional advice.
The mandate should identify how the PRRC function is organised, how regulatory issues are escalated and how continued availability is maintained during absence or organisational change. See the MDRC guide explaining the PRRC under the MDR and IVDR.
08
The mandate needs a working information system #
A contract can reproduce Article 11 perfectly and still fail in practice if the representative receives information late, in an uncontrolled format or only after an authority has intervened.
Declarations, certificates, technical documentation and current revisions
Intended purpose, design, manufacturing, software and supplier changes
Complaints, incidents, trends, field actions and emerging risks
Actor, device, UDI and certificate information relevant to EUDAMED
Names, addresses, contacts, ownership and responsible personnel
Deadlines, requested evidence, samples, access and response status
The manufacturer should provide the representative with permanent access to the documentation needed for its duties throughout the applicable retention period. Under the MDR, documentation is generally retained for at least ten years after the last device covered by the Declaration of Conformity has been placed on the market, or fifteen years for implantable devices. Under the IVDR, the general period is ten years.
The agreement should define repositories, document owners, notification triggers, response times, languages, emergency contacts and escalation routes. The practical objective is simple—when an authority asks a question, both parties should know who acts, which controlled record is used and when the response is due.
09
Liability does not turn the representative into the manufacturer #
The Authorised Representative has independent regulatory duties and may face consequences if it does not perform them. The Regulations also establish conditional joint and several liability where a manufacturer established outside the Union has failed to comply with its applicable obligations and the device is defective.
This does not mean that the parties share every obligation equally. The manufacturer remains responsible for the design, manufacture and conformity of the device. The representative is responsible for the duties it accepts under the Regulation and the mandate.
Because the representative carries its own regulatory exposure, it needs enough independence to challenge incomplete documentation, request corrective action and terminate the mandate if the manufacturer remains non-compliant.
Commercial clauses on liability allocation, indemnification and insurance may manage the relationship between the parties, but they cannot remove rights or protections created by Union law.
10
Changing representatives requires a controlled handover #
Changing the Authorised Representative is not complete when one contract is terminated and another is signed. Article 12 requires the manufacturer, outgoing representative and incoming representative to define a controlled transition.
End date of the outgoing mandate
Start date of the incoming mandate
Updated labels and supplied information
Document and complaint transfer
The change agreement should address the dates on which each mandate ends and begins, the date until which the outgoing representative may remain identified in manufacturer information, document transfer and confidentiality.
The outgoing representative must also forward complaints and suspected incident reports received after the end of the mandate to the manufacturer or incoming representative. Registrations, labels, certificates and communications with the Notified Body or authorities may also need coordinated updates.
11
A practical mandate checklist #
A useful agreement combines the regulatory minimum with operational detail. It should normally address the following subjects.
Legal names, addresses, contacts and evidence of EU establishment
Covered generic groups, models, identifiers, classes and regulations
Complete mandatory tasks and the procedure used to perform them
Clearly separated support that does not transfer manufacturer obligations
Repositories, retention, languages, version control and availability
Complaints, incidents, trends, field action and emergency escalation
Device, QMS, certificate, supplier and organisation changes
Qualification, continuous availability, escalation and continuity
Corrective steps, suspension, termination and authority notification
Handover obligations when the representative changes
Fees, liability, insurance, confidentiality and data protection
Reviews, audits, responsible persons, response times and governing law
A generic template may reproduce Article 11 but still leave the relationship unworkable. The best mandate shows how the duties will operate for the manufacturer’s actual devices, documentation system and post-market processes.
Conclusion
A strong mandate makes responsibility visible
The Authorised Representative mandate is not intended to move the manufacturer’s regulatory system into the European Union. It creates a reliable EU interface around that system.
The representative verifies specified outputs, retains access to evidence, communicates with authorities, forwards safety information and acts when the manufacturer is non-compliant. The manufacturer continues to own the device, its conformity and its lifecycle obligations.
When that division is written clearly—and supported by a working information flow—the mandate becomes more than a contractual formality. It becomes part of the regulatory control system supporting continued EU market access.
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