Eu IVDR Compliance Authorized Representative Service

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

An EU IVDR authorised representative (AR/EC REP) service is a legally defined appointment for an in vitro diagnostic (IVD) manufacturer established outside the EU—not a substitute for CE conformity assessment. Before requesting a quote, identify the legal manufacturer, the IVD generic device group and whether the product is being placed on the Union market.

A workable engagement has three outputs: an accepted written mandate, a controlled IVDR document-and-incident interface, and a functioning EUDAMED handoff. The manufacturer remains responsible for its non-delegable IVDR duties.

Decision gate: does this IVD need an EU authorised representative?

Use the identity of the legal manufacturer, not the location of its warehouse, distributor or parent company. Article 11(1) and (2) of Regulation (EU) 2017/746 control the answer.

Scenario	IVDR consequence	Practical next step
Non-EU legal manufacturer placing an IVD on the EU market	Appoint one EU-established AR for each covered generic device group; written acceptance is essential.	Map models to generic groups before signing the mandate.
EU-established legal manufacturer	Article 11 does not require an AR merely because production is outside the EU.	Confirm who is legally named manufacturer on the device.
Non-EU sponsor conducting only an IVD performance study	The study sponsor’s EU legal-representative rules under Article 58(4) are separate; do not treat an Article 11 AR as automatically fulfilling them.	Check study status, sponsor and applicable performance-study route.
Several different generic IVD groups	Different ARs may be possible for different groups, but not overlapping ARs for the same generic group.	Create a device-group-to-mandate register.

Mandate acceptance: the minimum Article 11 control set

A contract describing only a mailing address is inadequate. The mandate, accepted in writing by the AR, must enable the minimum Article 11(3) tasks:

Verify that the EU declaration of conformity and technical documentation exist and that the relevant conformity assessment has been performed where applicable (11(3)(a)); this is not automatic certification or a full technical-file audit.
Keep accessible copies of the technical documentation, declaration and applicable notified-body certificates, including amendments, for the IVDR retention period (11(3)(b); Article 10(7)). Under Article 10(7), the IVDR file-availability period is generally at least 10 years after the last device covered by the EU declaration of conformity is placed on the market.
Register the AR as an economic operator and verify the manufacturer’s device-registration compliance (11(3)(c); Articles 28 and 26).
Respond to authorities with conformity records in the required official Union language; relay device/sample requests and verify access (11(3)(d)–(e)).
Cooperate in preventive or corrective measures, promptly relay suspected-incident complaints, and terminate if the manufacturer acts contrary to IVDR obligations (11(3)(f)–(h)).

Article 11(4) bars transfer of specified manufacturer obligations under Article 10. Under Article 11(5), joint and several liability for defective devices arises under the stated conditions when the non-EU manufacturer has failed Article 10 duties; it is not an unconditional guarantee by the AR. Assess the AR’s competence, document access, continuity and liability terms before signature.

Pre-appointment evidence pack: what to supply and what it proves

A provider can scope the mandate only when the covered portfolio and compliance maturity are clear. Request a gap list for missing materials rather than a premature assurance of market readiness.

Legal-manufacturer corporate details, registered address and contact owner → confirms who gives the mandate.
Product/model list, intended purpose, IVD status and Annex VIII risk class rationale (A–D) → identifies generic groups and any notified-body dependency.
CE declaration of conformity, technical-documentation index (Annexes II–III), relevant certificates and validity status → enables the Article 11(3)(a)–(b) checks.
Current labels and instructions, including the proposed AR name/address placement under Annex I section 20.2(d) → prevents release with incorrect identification.
UDI/Basic UDI-DI and existing EUDAMED actor/device status → identifies registration and mandate-verification work.
PMS, performance-evaluation and vigilance contacts; incident/complaint escalation rules → makes the authority interface operational.
Any IVDD legacy-transition evidence, existing AR agreement, notified-body application/agreement and open corrective actions → detects route or transfer conflicts.

Red flags before acceptance: missing device scope, expired or unsupported CE basis, no document retrieval owner, or an existing unclosed mandate for the same generic group. An AR appointment cannot by itself cure these defects.

Responsibility matrix: avoid buying the wrong service

These are distinct legal actors. Procurement terms should assign operational help without silently shifting statutory responsibility.

Party	Core responsibility	What the AR can—not—replace
Non-EU manufacturer	IVDR conformity, risk/classification, technical evidence, CE declaration, QMS, UDI and device registration.	AR may assist, but non-delegable Article 10 obligations remain with the manufacturer.
EU authorised representative	Accepted Article 11 mandate; document availability, verification, authority cooperation and complaint forwarding.	Does not issue notified-body certificates or approve an otherwise non-compliant device.
EU importer	Independent Article 13 checks, including that an Article 11 AR has been designated.	Importer status does not automatically create a valid written AR mandate.
Notified body, if required	Independent conformity assessment for applicable IVDR classes/routes.	Appointment of an AR is not a substitute for notified-body involvement.

EUDAMED handoff after 28 May 2026

The first four EUDAMED modules became mandatory on 28 May 2026: actor registration, UDI/device registration, notified bodies/certificates and market surveillance (the last is principally for authorities). Do not confuse this activation with a blanket requirement to complete every legacy-device entry on the same day; transitional entry rules must be checked for the particular portfolio.

For IVDR-compliant devices first placed on the Union market from 28 May 2026, device data are generally due before the first placing. For qualifying legacy or IVDR-compliant devices first placed before 28 May 2026 and continuing to be placed on the market from that date, the Commission's EUDAMED transition infographic identifies 28 November 2026 as the device back-registration deadline. 27 November 2026 is a conservative internal completion target, not the date shown as the deadline in that infographic. Do not apply this deadline indiscriminately to historic stock already placed on the market, or to devices no longer placed on the market; verify the exact Article 113(3)(fa) conditions and current Commission guidance. Performance-study devices and IVDD legacy cases require route-specific checks.

Verify the AR is an existing registered actor in EUDAMED before the non-EU manufacturer submits its actor registration.
Record the manufacturer’s mandate information; obtain AR verification of the indicated mandate in the actor workflow. Include the EUDAMED PDF mandate summary stating the parties, mandate start date, optional end date and covered generic device groups; the AR verifies that submission. The summary is not a replacement for the written mandate accepted under Article 11.
Verify who will enter the manufacturer’s UDI/device data and when. The manufacturer retains the underlying registration obligation even if a service provider gives technical help.
Assign ownership of corrections, changes and mandate termination in EUDAMED; keep the signed mandate and registration evidence aligned with labels.

For the initial non-EU manufacturer actor request, the designated AR verifies the actor-registration request; additional mandates are also verified through the mandate-management workflow. The mandate-summary PDF must state the start date and an end date only if applicable.

EUDAMED is not an IVDR CE certificate or an automatic market-access approval. Review the Commission’s implementation guidance for device-specific registration transition dates.

Three cases that change onboarding

Legacy IVDD products: transitional access under amended Article 110 is conditional, not a general exemption from representation or post-market duties. Check original declaration/certificate, no-significant-change condition, QMS, notified-body application and signed agreement deadlines for the class; do not infer eligibility from an old CE mark. As of October 2026, the relevant Article 110 notified-body application/agreement milestones have already passed for qualifying class D (2025) and class C (2026) routes. For qualifying class B and sterile class A routes, the application and signed-agreement milestones are 26 May and 26 September 2027 respectively. Certificate-based cases and all other conditions still need independent verification; an AR cannot retroactively cure a missed milestone.
Non-sterile class A IVDs that did not need notified-body involvement under IVDR are not covered by the Article 110 extended legacy route; they have generally needed IVDR compliance since 26 May 2022.
Changing AR: Article 12 requires arrangements addressing exit and start dates, continuing use of the old name, document transfer and forwarding of complaints. Plan EUDAMED mandate changes and label stock disposition before terminating the former mandate.
Performance study only: confirm whether Article 58 sponsor representation applies. An EU AR under Article 11 and a study sponsor’s legal representative are different legal roles.

What to put in an IVDR AR service statement of work

Obtain a written proposal defining the legal entity accepting the mandate and measurable deliverables, not a claim that one “EU representative certificate” grants market access.

Named generic device groups/models, covered manufacturer and exclusions; identify future additions by change-control process.
Mandate version, effective date, authorised contacts, document-access method, retention and cybersecurity/confidentiality arrangements.
EUDAMED actor and mandate verification steps; device-data support scope, assigned operator and evidence of completed actions.
Authority-response languages, escalation and incident handoff, coverage during staff absence, and complaint-forwarding records.
Remediation, new certificates, label updates, representation switch and exit/handover charges, if any, disclosed in the commercial quote.

Next action: send the seven-item evidence pack and a model-to-generic-group table; ask the candidate AR to return a draft Article 11 mandate, an EUDAMED responsibility allocation and a written list of unresolved compliance conditions. For adjacent work, see:

IVDR authorised representative: specific questions

Can a distributor be our EU AR?

Potentially, if it is EU-established, accepts a compliant written Article 11 mandate and can actually fulfil the duties. Its commercial role alone is insufficient; examine role conflicts and continuity.

Does our class A self-declared IVD still require an AR?

Yes if the legal manufacturer is outside the EU and the IVD is placed on the Union market; notified-body exemption does not remove Article 11. Class A sterile status may affect the separate conformity-assessment route.

Does an EU subsidiary remove the AR requirement?

Not automatically. Determine whether the EU entity is itself the legal manufacturer. A sales subsidiary or EU warehouse does not by itself change who manufactures under its name or trademark.

May the AR register our devices instead of us?

It may provide agreed technical assistance, but the manufacturer retains the Article 26 registration obligation; the AR has its own Article 28 registration and Article 11(3)(c) verification duties.

Can we replace the AR without restarting CE conformity assessment?

A representative change does not, solely by itself, establish that a new conformity assessment is required. Check Article 12 handover, current certificates and product changes, labelling and EUDAMED records before continuing market supply.