European Authorized Representative EC REP

European authorized representative
for medical devices

for manufacturers of medical devices outside the EU

A non-EU manufacturer without an authorized representative cannot sell in Europe. But an administrative representative without technical competence exposes the manufacturer to growing legal risk. ISOFAC GROUP operates the mandate with a dedicated PRRC, a prior documentary audit, and active regulatory monitoring.

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MDR 2017/745 Dedicated PRRC SRN FR-AR-000053751 ISO 13485

Why the choice of authorized representative has become a legal decision

In 2021, designating a European authorized representative was primarily a registration formality. That is no longer the case. Two texts have fundamentally restructured expectations.

The MDCG 2022-16 (opens in a new tab) guidance requires the authorized representative to conduct genuine documentary verification: consistency between the declaration of conformity and the technical documentation, validity of certificates, the manufacturer’s product liability insurance coverage. A formal review is no longer sufficient. It demands effective technical competence on the representative’s side.

Directive 2024/2853, adopted in October 2024 and applicable in 2026, broadens the definition of defect to include software, artificial intelligence, and cybersecurity failures. It simplifies the burden of proof for victims. Combined with Article 11(5) of the MDR, which makes the authorized representative jointly liable with the manufacturer, it gives the mandate a new legal weight.

Choosing an authorized representative who ticks the Article 11 boxes without substantive verification means transferring growing legal risk onto a structure that does not see it coming.

The manufacturers for whom ISOFAC GROUP operates the mandate

Covered profiles

  • Following the non-renewal of the Switzerland-EU MRA on 26 May 2021, officially published by Swissmedic, Swiss manufacturers are treated as non-European Union manufacturers under MDR 2017/745.
  • Post-Brexit British manufacturers, required to designate an EU authorized representative distinct from their UK Responsible Person.
  • North African and Middle Eastern manufacturers for whom French-speaking representation and proximity to their historical export markets constitute an operational advantage.
  • Asian and North American manufacturers who choose a close-knit contact rather than a large logistics structure based in the Netherlands or Germany.

Outside scope, for transparency

  • Manufacturers established in an EU member state, Norway, Liechtenstein, or Iceland do not require an authorized representative.
  • Implantable medical devices, Class III devices, devices incorporating a medicinal substance or a component of animal origin fall outside ISOFAC GROUP’s current scope.
  • Devices covered by the IVDR are not covered at this stage.

For these categories, we refer to firms with the appropriate experience and coverage. For regulatory strategy or advisory needs, see our consulting offering.

Four steps, from audit to ongoing surveillance

Step 01

Pre-mandate audit

Before any signature, ISOFAC GROUP reviews the available technical documentation, verifies consistency with the declaration of conformity, examines the notified body certificate where the device class requires it, and checks the existence and coverage of product liability insurance. This audit may lead to redefining the scope of the mandate. It is the filter on which everything else depends.

Step 02

Contractualisation under Article 11(3) MDR

The contract specifies the exact scope of the devices covered by generic group, the manufacturer’s obligations under Article 11(4), the terms of incoming or outgoing transition under Article 12, and termination conditions. Recommended minimum duration: three years, aligned with certification cycles.

Step 03

EUDAMED registration and manufacturer SRN

The non-EU manufacturer submits its own actor registration request in EUDAMED and registers its devices (Art. 29 and 31). As authorized representative, ISOFAC GROUP, registered in its own name (Art. 31), verifies and confirms the manufacturer’s request and the mandate summary, then verifies that the manufacturer has fulfilled its UDI and device registration obligations (Art. 11(3)(c)). We can provide the manufacturer with technical support for these entries. Once the file is complete, validation by the competent authority (ANSM) usually takes two to three weeks; the manufacturer then obtains its own SRN.

Step 04

Operational monitoring and vigilance

Keeping technical documentation up to date, handling authority requests within required timelines, forwarding complaints and incidents to the manufacturer upon receipt, cooperating with FSCAs, maintaining traceability of documentary checks. A periodic review verifies that the portfolio remains within the covered scope and that the manufacturer’s liability insurance is still adequate.

A dedicated PRRC, compliant with MDCG 2019-07 Rev.1

Article 15 of the MDR requires authorized representatives to have at least one person responsible for regulatory compliance at all times. MDCG 2019-07 Rev.1 (opens in a new tab) (December 2023) sets a non-negotiable rule: the authorized representative’s PRRC and the represented manufacturer’s PRRC cannot be the same person, even within a shared organizational structure. It is this functional independence that justifies the double oversight required of non-EU manufacturers.

ISOFAC GROUP has a PRRC dedicated to its authorized representative activity, distinct from any manufacturer PRRC role. This configuration is documented and enforceable.

Bilingual support FR · EN

EC REP European authorized representative MDR pricing: our public rate card

ISOFAC GROUP publicly discloses the entry-level range of its offering. This choice pre-screens manufacturers for whom the cost of a professionally operated mandate is not compatible with their business model.

Public entry-level pricing

From  € 2,880 / year

Plus €800 onboarding fee in the first year.

  • Number of devices under mandate
  • Device class covered
  • Technical documentation complexity
  • Ancillary services

The final rate is set following the pre-mandate audit, based on a specific quotation.

Complementary service

Free Sale Certificate (FSC)

Free Sale Certificate required for the export of medical devices outside the EU. File compilation, application to the competent authority, conformity verification.

View the dedicated page

FAQ

Frequently asked questions

Allow four to six weeks between the first exchange and the effective launch of the mandate: one to two weeks for the pre-mandate audit and contractualisation, two to three weeks for EUDAMED validation by the competent authority once the file is complete.
The MDR does not explicitly prohibit this combination. In practice, this configuration raises an independence issue: an authorized representative who commercially distributes the devices it is supposed to monitor places its commercial interests and its regulatory obligations in documented tension. MDCG 2022-16 requires the authorized representative to conduct substantive documentary verification and maintain an independent view on compliance. ISOFAC GROUP does not combine these roles, precisely to preserve that independence.
Where the mandate is terminated because the manufacturer acts contrary to its obligations, the authorized representative immediately informs the competent authority of its member state and, where applicable, the notified body (Art. 11 §6). Any change of authorized representative is governed by an agreement between the manufacturer, the incoming authorized representative and, where practicable, the outgoing one (Art. 12): end and start dates of the mandate, transfer of documents, forwarding of complaints. The manufacturer must designate a new authorized representative before the current mandate ends in order to maintain its access to the European market.
Three straightforward checks: is its SRN visible in EUDAMED? Is its PRRC distinct from any manufacturer PRRC in its portfolio? Can it produce documentation evidencing the documentary checks performed on your devices? If any of these questions goes unanswered clearly, it is a warning signal.
The European authorized representative (EC REP) is the natural or legal person established in the EU who represents the non-European manufacturer before the competent authorities. Article 11 of the MDR imposes specific obligations: verifying that the manufacturer has itself fulfilled its EUDAMED registration obligations (Art. 11(3)(c)), keeping the technical documentation and declaration of conformity available, cooperating with competent authorities, and acting in the event of corrective action or product recall. The authorized representative is jointly liable with the manufacturer for defective devices. This is not a passive administrative role: it carries legal responsibility.

Become an EC REP client with ISOFAC GROUP
The choice of authorized representative must be based on several concrete criteria: verifying its active registration on EUDAMED (the SRN must be publicly searchable), its capacity to keep the technical documentation of the devices it represents available, its responsiveness in the event of a vigilance incident, and its genuine knowledge of the MDR and of competent authority expectations. Beware of purely administrative offerings without technical competence: in the event of an inspection, the authorized representative must be able to respond substantively to the authorities. ISOFAC GROUP is registered on EUDAMED under SRN FR-AR-000053751, verifiable online.

Verify our EUDAMED registration
Changing authorized representative is a regulated procedure. It involves: terminating the contract with the outgoing authorized representative in accordance with agreed terms, designating the new authorized representative by written contract, updating the EUDAMED registration (modifying the link between the manufacturer and its EC REP), and updating the device labelling with the new authorized representative's details. This last point may require a transition period, particularly for products already in distribution. During the transition, liability may remain shared. Rigorous coordination between the two authorized representatives is essential.

Discuss your EC REP transition with ISOFAC GROUP
The SRN (Single Registration Number) is the unique identification number assigned to each economic operator registered on EUDAMED. The non-EU manufacturer submits its own actor registration request in EUDAMED and registers its devices (Art. 29 and 31): it receives its own SRN, and the authorized representative does not hold its account. As authorized representative, ISOFAC GROUP registers in its own name (Art. 31), verifies and confirms the manufacturer's request and the mandate summary, then verifies that the manufacturer has fulfilled its UDI and device registration obligations (Art. 11(3)(c)). We can provide the manufacturer with technical support for these entries. The SRN identifies the economic operator; it appears in particular in the EU declaration of conformity and in certificates, and it is publicly verifiable in EUDAMED. It is not a mandatory labelling item. It constitutes proof that the economic operator is registered, a necessary but not sufficient condition for MDR compliance.

Prepare your EUDAMED registration with ISOFAC GROUP
Yes. Since the medical devices chapter of the Mutual Recognition Agreement (MRA) between Switzerland and the EU was not updated in May 2021, Swiss manufacturers are treated as third-country manufacturers for the purposes of the European market. They must therefore designate an MDR European authorized representative to commercialise their devices in the EU, just as a US or Japanese manufacturer would. The CH-REP (Swiss representative) is a separate obligation, valid solely for commercialisation in Switzerland under the Medical Devices Ordinance (MedDO, SR 812.213). The two roles can be combined contractually, but they correspond to two separate legal obligations within two distinct regulatory frameworks.

EC REP service for Swiss manufacturers

Describe your need

A written, reasoned reply within 48 working hours. If your request falls outside our scope, we point you to the right resource.

Before appointing an authorised representative

Three in-depth analyses from our regulatory resources: selection criteria, the pricing models found on the market, and the real scope of Article 11 obligations.

How to choose your authorised representative: the criteria that non-EU manufacturers overlook

Beyond the annual fee, an EU authorised representative is judged on its ability to actually perform the tasks set by the MDR: keeping the required documents, cooperating with authorities, relaying sensitive requests, framing vigilance and maintaining a regulatory organisation separate from the manufacturer's.

What an authorised representative really costs: price ranges, models and what to avoid

There is no official price list in Europe: some offers start at around €1,600 for the first year, others run to several thousand euros. The gap has less to do with the headline price than with what the mandate actually covers.

EC REP under MDR: obligations, responsibilities, and what the authorised representative can and cannot do

The authorised representative verifies, retains, checks and cooperates — it does not become the manufacturer in the manufacturer's place. Its joint liability is neither general nor automatic: it concerns defective devices, under the precise conditions of Article 11.

All regulatory resources

Open an EC REP mandate with ISOFAC GROUP

The first exchange lasts 30 minutes. It allows us to qualify the exact scope, verify that your devices fall within the covered perimeter, and schedule the pre-mandate audit. No commitment at this stage. Allow four to six weeks between this exchange and the effective launch of the mandate.

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