Eu Mdr Medical Device Compliance Authorized Representative Service

Scope and evidence must be confirmed before any paid tests or filings.

For a medical-device manufacturer established outside the EU, an EU authorised representative (EU AR or EC REP) is a regulated appointment—not a mailing address, distributor licence or substitute for CE conformity assessment. Under Article 11 MDR, a device may be placed on the Union market only if a sole representative is designated for its generic device group and accepts a written mandate.

The service decision is whether a proposed representative can lawfully accept the precise product groups, verify the required evidence, operate the authority-contact process and stay available throughout the device lifecycle. Appointment alone does not prove that any device complies with the MDR.

Do you need an MDR representative for this portfolio?

Identify the legal manufacturer, intended purpose and applicable regime before discussing prices. An EU importer does not automatically become the manufacturer's authorised representative; each role has different obligations. This is a portfolio-scoping decision, not a country-by-country choice of agent.

Portfolio situation	Representative decision	Verification before appointment
Non-EU manufacturer placing MDR devices on the EU market	Designate one EU-established AR per generic device group; the mandate must be accepted in writing.	Check legal manufacturer, generic groups, device classes and market-entry status.
Manufacturer established in an EU Member State	The Article 11 non-EU-manufacturer appointment rule does not apply.	Verify actual legal establishment and manufacturer identity; an EU warehouse alone is not proof.
In-vitro diagnostic (IVD) product	Assess a separate appointment under IVDR 2017/746, not the MDR mandate for this page.	Confirm intended purpose and IVD classification; use the IVDR-specific route.
Custom-made, legacy or investigation-only scenario	Do not assume the ordinary CE-device checklist applies unchanged.	Check Annex XIII or transition status; an investigation sponsor’s legal representative is a distinct role.

Written mandate: what must be agreed before acceptance

Articles 11(2)–(4) require written acceptance and minimum statutory tasks. Coverage extends at least to all devices in each generic device group identified; different generic groups may have different representatives, but not competing representatives for the same group. A group-by-group schedule with model identifiers avoids accidental gaps.

The contract must give the AR working access to current records and a practical route to respond to authorities. It cannot transfer the manufacturer's non-delegable Article 10 duties—such as conformity assessment, technical-documentation creation, QMS and post-market surveillance—to the AR. Extra services may be contracted separately, without changing the legal allocation of duties. Under Article 10(8), copies remain available for at least 10 years after the last device covered by the declaration is placed on the market, or 15 years for implantable devices. For a manufacturer outside the Union, Annex I, section 23.2(d), requires the AR's name and registered address on the MDR device label.

Names and legally established addresses of both parties; start date and groups/models covered.
Article 11(3)(a)–(h) tasks, authority communications, complaint forwarding and corrective-action cooperation.
Uninterrupted access to current technical files, EU declarations and applicable notified-body certificates.
Record-update ownership, secure access, incident escalation contacts, termination and handover protocol.

Appointment-readiness dossier: eight items to request

Use this as a document-transfer checklist before signing, not as a claim that every file is sufficient or that the AR certifies the device. For a custom-made or legacy device, adapt the list to the applicable legal pathway.

Legal manufacturer's full name, non-EU address and responsible regulatory contact.
Device-family and model list, intended purpose, MDR class, Basic UDI-DI where applicable and generic-group mapping.
Current EU declaration of conformity, with scope matched to listed devices (where applicable).
Technical documentation and version-controlled access under MDR Annexes II and III or applicable special provisions.
Notified-body certificate, annexes, amendments and validity/status where the conformity route requires it.
Artwork of labels/IFUs showing proposed manufacturer and AR details; check applicable language requirements.
EUDAMED actor/SRN information, mandate relationship and device-registration responsibilities/status.
Complaint, vigilance, field-safety and corrective-action contacts; open issues and pending authority requests.

Who does what after the mandate?

Use the responsibility matrix to avoid buying an 'all-in-one CE registration' promise that blurs legal accountability. As a general MDR rule, an AR must have a person responsible for regulatory compliance (PRRC) permanently and continuously at its disposal under Article 15(6); the MDCG describes a specific legacy-device qualification to assess. Article 11(5) also provides conditional joint-and-several liability of the AR for defective devices where the non-EU manufacturer has not complied with Article 10. This is a legal risk to assess during provider due diligence, not an automatic CE guarantee.

Actor	Minimum operational responsibility	Boundary
Manufacturer	Own compliance, technical documentation, QMS, conformity, vigilance and device/UDI data.	Article 10 duties listed in Article 11(4) cannot be delegated by mandate.
Authorised representative	Verify required records/process, hold available copies, register its actor, verify manufacturer registration, communicate and cooperate with authorities.	Does not grant CE certification or replace the manufacturer.
EU importer	Independently check CE mark, declaration, AR designation, labelling and applicable UDI under Article 13.	Importer verification is not an AR mandate.
Notified body / competent authority	Notified-body certification where required; authority validation, supervision and enforcement.	The AR does not approve the device or issue an SRN.

MDCG 2022-16 clarifies two cumulative elements for potential Article 11(5) joint liability: the manufacturer must be liable for a defective device under applicable product-liability law, and its failure to comply with Article 10 must be established. Courts determine disputed liability. The same guidance states that a representative is not required to appoint a PRRC for legacy devices covered by its mandate; assess the status of each group rather than applying that exception to new MDR devices.

EUDAMED in 2026: distinguish actor, mandate and device records

Since 28 May 2026, the Actor, UDI/Device, Notified Bodies & Certificates and Market Surveillance modules have been mandatory to use, subject to applicable transitional rules. The two other EUDAMED modules are not yet mandatory. The AR must meet its own Article 31 actor-registration obligations and verify the manufacturer's Article 27/29 obligations; the manufacturer remains responsible for its own device-registration duties.

For a non-EU manufacturer, the actor/mandate workflow requires an AR relationship in EUDAMED; the mandate is verified by the AR. An SRN is issued through the competent-authority validation process, not sold or issued by a commercial representative. Check existing actor records and whether the generic groups in the mandate match the database relationship before declaring onboarding complete.

For a practical EUDAMED mandate check, match the signed scope against the manufacturer’s mandate entry and the AR’s verification status. The Commission’s mandate-summary workflow identifies the parties and their addresses, mandate dates and the generic device groups; an additional mandate submitted by the non-EU manufacturer is verified by the AR. The Market Surveillance module is for competent authorities and the Commission, not an extra commercial filing service for ARs. Check device-specific transitional registration rules rather than assuming all older device entries fell due on 28 May 2026.

Service operations after signing: five controls

The AR role continues beyond onboarding. Article 11(3) includes responding to authority requests in the required official Union language, forwarding requests for samples, cooperating on preventive/corrective action and immediately passing on complaints or suspected-incident reports to the manufacturer. The manufacturer retains incident-reporting and safety responsibilities.

Designate authority and manufacturer contacts, deputies and an accessible document repository.
Track certificate, declaration, device-scope and label changes; refresh copies supplied to the AR.
Triage authority requests, coordinate sample access and preserve the request/response audit trail.
Immediately route complaints and suspected incidents to the manufacturer; coordinate escalation and corrective actions.
Review role data, EUDAMED records and mandate scope whenever device groups or business entities change.

Switching an EU AR without creating a representation gap

Article 12 requires a clearly defined change agreement between the manufacturer, the outgoing AR where practicable and the incoming AR. A simple cancellation email is not an adequate handover plan. The outcome depends on live product distribution, label stock, access to records and authority correspondence.

Align the outgoing mandate end date with the incoming mandate start date.
Define the last date on which the outgoing AR may appear in supplied information and promotional material; review labels/IFUs.
Transfer documents subject to confidentiality and intellectual-property arrangements.
Preserve forwarding of post-termination complaints and suspected-incident reports; update relevant EUDAMED mandate data.

How to scope an AR service proposal

Send the manufacturer identity and country, a model-by-model device schedule, MDR/IVDR pathway, class, declaration/certificate status, EUDAMED/SRN status, intended launch markets and any incumbent AR contract. Ask the prospective AR to identify its EU legal entity, Article 15(6) PRRC arrangements, specific generic-group coverage, document-access method, authority-response process, exclusions and termination/handover terms. Price depends on portfolio complexity and continuing workload; there is no universal MDR statutory AR-service fee or assured onboarding timeframe.

A broader EU representative overview explains cross-sector roles. For classification and remediation use MDR compliance consulting; for the mechanics of filing use MDR registration services. For diagnostics follow IVDR authorised representation.

Official legal and implementation sources

MDR authorised representative: practical FAQ

Does a Class I device from a non-EU manufacturer need an AR?

Yes, where an MDR device is placed on the Union market by a non-EU manufacturer; Class I does not create a general Article 11 exemption. Its conformity route still needs separate assessment.

Can a distributor be our EU AR?

Potentially, if legally established in the Union and able to accept and fulfil the written Article 11 mandate. Conflicts, document access and regulatory competence must be assessed; distribution alone does not confer the role.

Can we appoint two ARs for different products?

Different generic device groups may have different ARs. Each generic group must have one sole AR and the written mandate must cover at least that whole group.

Does an AR perform or guarantee CE certification?

No. An AR verifies that required documents and, where applicable, conformity assessment exist; the manufacturer remains responsible for compliance, with a notified body involved when the route requires one.

Can the AR register our products in EUDAMED instead of us?

The AR has its own actor-registration duties and verifies the manufacturer’s UDI/device-registration compliance. Administrative support can be agreed, but the manufacturer’s statutory responsibility is not transferred.

What happens if the manufacturer refuses necessary corrective action?

The Article 11(3)(h) mandate must provide for termination where the manufacturer acts contrary to MDR obligations; an identified refusal requires the facts and corrective-action options to be assessed, not an invented universal grace period. If the AR terminates on that ground, Article 11(6) requires immediate notice to its competent authority and, where applicable, the notified body, stating the reasons.