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 file, 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 file, 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 SRN device assignment

ISOFAC GROUP registers the manufacturer in EUDAMED and obtains the Single Registration Number. The standard ANSM validation timeframe is two to three weeks once the file is complete. Upon completion, the authorized representative and the devices are publicly visible in EUDAMED.

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.

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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  € 2,400 / year

Plus €800 onboarding fee in the first year.

  • Number of devices under mandate
  • Device class covered
  • Technical file 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.
The outgoing authorized representative is required to notify the relevant member state and notified body, and to retain certain documents available to authorities for the periods stipulated by the MDR (10 to 15 years depending on the case). 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: registering the manufacturer and its devices on EUDAMED, 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. For a non-EU manufacturer, it is the authorized representative who initiates the registration procedure with the national competent authority of its country of establishment. Once the manufacturer SRN is obtained, the authorized representative registers the relevant devices, links the certificates of conformity, and keeps this data up to date. The SRN must appear in the labelling and is publicly verifiable on the EUDAMED portal. It is the tangible proof that the manufacturer is in compliance with its MDR obligations.

Delegate your EUDAMED registration to ISOFAC GROUP
Yes. Since the suspension of the Mutual Recognition Agreement (MRA) between Switzerland and the EU 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 MedDO. 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.

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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