Eu IVDR Compliance Authorized Representative Service In France

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

A French EU authorised representative (AR, or mandataire) service is relevant to a manufacturer of in vitro diagnostic medical devices (IVDs) established outside the EU that intends to place covered devices on the Union market. The appointment concerns a defined device portfolio, not a blanket approval to sell in France.

The decision has two layers: the EU-wide written IVDR mandate under Article 11, and France-specific language and vigilance arrangements if devices are supplied in France. A representative need not be established in France merely because French customers are targeted.

EEA classification check: Norway, Iceland and Liechtenstein participate in the EEA framework. Do not automatically treat a manufacturer legally established there as a third-country manufacturer merely because it is outside the EU; verify the EEA application and the real manufacturer establishment before ordering an Article 11 mandate. A warehouse or importer address does not by itself establish the manufacturer.

Decision matrix: is an IVDR representative required for your French launch?

Identify the legal manufacturer, the intended purpose and route to market before appointing a representative. A French importer, distributor or consultant does not automatically replace an Article 11 AR.

Manufacturer and device situation	AR decision	Action before supply in France
Non-EU manufacturer; new IVD sold to French users	Appoint one EU-established AR for each generic device group; a French address is an option, not a France-only legal condition.	Classify under IVDR Annex VIII; select the applicable conformity-assessment route; obtain written acceptance of the mandate before placing on the market.
Non-EU manufacturer; existing IVDD/legacy IVD	An AR is still required; a legacy label or previous mandate must not be presumed sufficient.	Document eligibility for Article 110 transition, including applicable conditions and prior deadlines; verify mandate and current documentation.
Manufacturer genuinely established in an EU Member State	Article 11 appointment for a non-EU manufacturer is not triggered.	Keep the manufacturer’s own IVDR obligations and French-language/vigilance checks; do not buy an unnecessary AR appointment.
Product used solely in an IVDR performance study	Do not assume a marketing AR appointment is the study sponsor’s legal representation.	Evaluate Article 58 study/sponsor arrangements separately before the study; do not present study-only supply as ordinary market placement.

What an Article 11 mandate for French-market IVDs must cover

A binding designation requires a written mandate accepted in writing by the AR. It must cover at least every device within the same generic device group. The manufacturer can use different ARs for genuinely different generic groups, but not two simultaneous ARs for one group.

Check that the EU declaration of conformity and technical documentation exist, and that the appropriate conformity assessment has been carried out where applicable; this is verification, not issuance of an IVDR certificate.
Keep the relevant documentation, declaration and notified-body certificate (if applicable), including amendments, accessible to authorities for the IVDR retention period—normally at least 10 years after the last covered IVD is placed on the market.
Perform Article 11(3) registration and authority-cooperation duties, relay requests for samples, forward complaints immediately, assist corrective actions and terminate the mandate if the manufacturer breaches IVDR duties.
Confirm the AR has continuous access to an appropriately qualified person responsible for regulatory compliance (PRRC) under Article 15(6), plus a documented escalation and document-access process.

An Article 11 mandate does not transfer the manufacturer’s non-delegable Article 10 obligations. Article 11(5) establishes conditional joint-and-several AR liability for defective devices where the non-EU manufacturer has not complied with Article 10; neither a “mailbox only” contract nor a sales-agent letter replaces the regulated role.

France-specific overlay: documents, ANSM and réactovigilance

France does not create a separate IVDR conformity mark. Its April 2026 implementing decree does, however, create practical handover tasks for devices placed on the French market.

Article R.5221-1 of the French Public Health Code requires French for end-user/patient labelling, accompanying instructions, other Annex I section 20 operational/use information, the EU declaration of conformity specifying the marketed trade name, and the field safety notice.
Under R.5222-5, manufacturers placing IVDs on the French market or their AR appoint a correspondant de réactovigilance, notify ANSM promptly of that person’s identity and capacity, and use a correspondent established in France or, failing that, another EU Member State.
French activity declarations under L.5221-4 additionally concern specified distributors supplying the French market (excluding sales to the public) and persons sterilising relevant devices in France. These are not an automatic separate French AR licence.
Where the AR is established in France, its EUDAMED actor application is assessed by the competent French authority; an AR established in another EU State follows that State’s competent-authority actor route. ANSM remains the French IVD market-surveillance and vigilance contact.

Assign the French translation owner and vigilance correspondent in the service contract. Do not treat an SRN, a French address or an ANSM exchange as product approval.

EUDAMED since 28 May 2026: who registers what?

The Actor, UDI/device, notified-body/certificate and market-surveillance modules became mandatory on 28 May 2026. Actor registration is distinct from device registration; it is not optional merely because an AR has been appointed.

Actor or data set	Responsible party and check
EU authorised representative	Registers its own AR actor details; retains its Actor ID/SRN and maintains its actor record.
Non-EU legal manufacturer	Submits its own manufacturer actor request and mandate summary; its nominated, already registered AR verifies the request before competent-authority assessment.
IVD UDI/device information	The manufacturer remains responsible for device registration; the AR verifies relevant manufacturer compliance under Article 11(3)(c). Contractual data-entry assistance is not legal transfer of responsibility.
Notified-body certificates	The notified body, not the AR or manufacturer acting as a notified body, registers the relevant IVDR certificate information in the NB/Certificates module; check certificate status separately from device registration.

UDI/device registration timing must be checked by marketing history, not inferred from the AR appointment. The four-module launch does not mean each actor files in all four modules: Market Surveillance is used by competent authorities. The EUDAMED Vigilance and Performance Studies modules are not yet mandatory.

First placing from 28 May 2026: register a new IVDR-compliant IVD in the UDI/device module before the first unit is placed on the EU market; confirm its conformity route separately.
First unit before 28 May 2026, further units placed afterwards: for covered IVDR and eligible legacy devices, the Article 113 transitional registration window runs until 28 November 2026. Check the legacy-device identification rules and avoid duplicating an IVDR registration of the same device.
No units newly placed after 28 May 2026: device registration is generally not required solely for historic stock, unless a relevant vigilance action requires it.
Devices solely for performance studies: do not use the ordinary UDI/device marketing-registration workflow; assess the separate study requirements.

Pre-appointment intake file: six items that make or break onboarding

Send a product-by-product index, not merely an unsigned appointment letter. The following is an operational document-request checklist, not an extra statutory filing list.

Legal entities: manufacturer’s exact registered name and country, proposed AR legal entity/address, existing AR and importer/distributor roles.
Portfolio scope: intended purpose, IVD/accessory status, device families/generic groups, SKUs, intended French users and target marketing date.
IVDR route: Annex VIII class A/B/C/D with reasoning; conformity-assessment plan and notified-body identity/certificate where needed (most routes other than class A non-sterile involve a notified body).
Evidence set: current declaration of conformity, technical-documentation index, performance evaluation and applicable certification, including controlled revisions and secure access.
Legacy status, if claimed: pre-26 May 2022 IVDD declaration/certificate, design-change log and evidence of Article 110 conditions and timely notified-body milestones. An extended end date alone proves nothing.
France operations: French versions of required information, label artwork with AR name/address, EUDAMED actor/SRN state, reactovigilance contact, complaints and authority-escalation owners.

Change or terminate an AR without losing traceability

Under IVDR Article 12, a change agreement between the manufacturer, outgoing AR where practicable and incoming AR must settle the end/start dates, last use of the former AR on labels/promotional information, transfer of documents and forwarding of later complaints. The practical handover should also reconcile EUDAMED records and inventory with the correct identification.

Avoid overlapping mandates for one generic group or gaps that leave a non-EU manufacturer without its required AR.
Record which device batches and labels show the outgoing AR, the cutover date, updated technical-documentation access and contact routes.
Route complaints, incident reports and field actions to the responsible manufacturer and relevant authorities; the AR must forward suspected-incident complaints to the manufacturer immediately.
When an AR terminates for manufacturer non-compliance under Article 11(3)(h), it must immediately inform its home competent authority and, where applicable, the notified body; a simple supplier cancellation email is not sufficient.

Service scope, exclusion checks and next safe action

A substantive AR-service proposal should specify the named legal entity, covered generic device groups, signed Article 11 mandate, document-access method, PRRC coverage, EUDAMED actor-verification and maintenance tasks, ANSM/French-vigilance contact workflow, complaint escalation, change control and exit assistance. It should state which certification, translation, device registration and vigilance work is included or separately commissioned.

Ask for evidence of the AR’s EU establishment, ability to satisfy Article 15(6) and practical access to controlled IVDR documentation.
Reject promises of “IVDR approval by appointment”, universal CE certification, an automatic French registration number for every product, or a guaranteed launch date.
Resolve classification and notified-body needs before treating the representation contract as a market-entry clearance.
If the device is already sold, changing class, crossing from a study into commercial supply or relying on legacy status, perform a device-specific regulatory review before changing labels.

Next step: provide the six-part intake file and ask a prospective EU-established representative for a device-group-specific Article 11 mandate and a written France/EUDAMED responsibility schedule. Until conformity and registration status are verified, do not infer that an IVD may be placed on the French market.

For EU-wide representation questions beyond the France operational layer, consult Related EU-wide IVDR representative guide

For the wider French CE conformity-assessment workflow, see CE marking services in France

IVDR authorised representative in France: practical questions

Must the authorised representative have a French registered office?: No. The IVDR requires an AR established in the EU for a non-EU manufacturer, not specifically in France. A France-based AR may be chosen for operational convenience; French language and vigilance obligations still apply to French-market devices.
Can our French importer double as the IVDR authorised representative?: It may be possible if that legal person is established in the EU, accepts an Article 11-compliant written mandate and can fulfil its independent obligations. Importer status alone does not confer AR status; examine conflicts, document access and continuity.
Can a non-EU manufacturer use an AR to self-certify a class C IVD?: No. Appointment is not a conformity-assessment shortcut. IVDR class and the applicable Article 48/notified-body route must be resolved first; the AR verifies existence of the relevant conformity evidence.
Does an older IVDD certificate or declaration automatically allow continued French sales?: No. Article 110 transition is conditional, with device-class-specific deadlines and historical QMS and notified-body milestones. Review the actual evidence and changes before asserting eligibility.
What if we replace an AR after products have been labelled?: Plan an Article 12 transfer agreement and precise labelling/document/complaint handover. Reconcile EUDAMED mandate information and product inventory; do not leave the generic device group without valid representation.