EU Authorized Representative FAQ: 23 Questions Answered from the MDR

Short answers to the questions manufacturers ask most often about the EU authorised representative under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Quotations are taken word for word from the consolidated texts on EUR-Lex; each answer links to the page where the topic is covered in depth.

The role

What is an EU authorised representative?

Article 2(32) of the MDR: "‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;" In practice the representative is the manufacturer's legal presence in the Union for the tasks listed in Article 11(3). Our EU authorized representative guide covers the role in full.

Who needs an EU authorised representative?

Every manufacturer without a registered place of business in a Member State. Article 11(1): "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." The obligation does not depend on class or volume. A short test is in do you need an EU authorised representative.

Can I appoint more than one representative?

Not for the same devices. Article 11(1) requires a sole representative, and Article 11(2) makes the mandate "effective at least for all devices of the same generic device group." Different generic device groups may, in principle, sit with different representatives; see the sole authorised representative rule.

When does the mandate become valid?

Only when the representative accepts it in writing. Article 11(2): "The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative". It has to be in place before the first device is placed on the Union market.

Can the representative be established in Türkiye?

Under the EU-Türkiye Customs Union arrangement, the Commission's notice to stakeholders treats a representative established in Türkiye as able to act for manufacturers outside both. The chain of instruments is set out in our note on the Customs Union legal basis.

The mandate and its limits

What must the mandate contain?

At least the tasks listed in Article 11(3), points (a) to (h): verification of the declaration of conformity and technical documentation, keeping documents available, registration duties, information and samples for authorities, forwarding requests, cooperation on corrective action, forwarding complaints and termination rights. A clause-by-clause template is in the mandate agreement under Article 11(3).

What can the representative not take over?

Article 11(4) keeps the core manufacturer duties with the manufacturer, among them the quality management system, technical documentation, conformity assessment and the declaration of conformity. See what an EU authorised representative cannot do.

Is the representative liable for defective devices?

Conditionally. Article 11(5): "Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." See authorised representative liability.

Does the representative need its own PRRC?

Yes. Article 15(6): "Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." See the PRRC under Article 15.

How do I change my representative?

Through a written agreement under Article 12: "The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative." The practical sequence is in how to change your EU authorized representative.

Labels, registration and documents

Does the representative's name go on the label?

Yes. Annex I Section 23.2(d) requires, "if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;" See labelling requirements and the EU REP symbol.

Does the representative register in EUDAMED?

Yes, as an actor with its own Single Registration Number under Article 31, and the manufacturer's actor record is linked to it through the mandate. See EUDAMED actor registration and the SRN.

How can I check a representative before signing?

In the public EUDAMED actor database. Article 31(7): "The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public." Our own record is TR-AR-000057550. More checks are listed in the buyer's checklist.

How long must the documents be kept?

Article 10(8) sets the period: "for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market." The representative keeps a copy for the same period under Article 11(3)(b).

What happens when a competent authority asks for documents?

The representative must provide them. The duties in Article 11(3)(d) and (e) are explained in competent authority requests.

Related roles and markets

Do I also need an importer?

Yes, where devices are imported into the Union. The importer is a separate economic operator under Article 13; see importer obligations and whether the representative can also be the importer.

Does an EU representative cover the UK and Switzerland?

No. Great Britain requires a UK Responsible Person and Switzerland a CH-REP, each under its own law. See EU AR, UK Responsible Person and Swiss CH-REP compared.

Does the same apply to IVD manufacturers?

Yes. Article 11 of the IVDR mirrors the MDR provision; see the IVDR authorised representative.

Do legacy devices need a representative?

Yes. Legacy devices remain subject to the MDR requirements on registration, vigilance and post-market surveillance under Article 120(3d); see the MDR transition period.

What happens if a manufacturer has no representative?

The device may not be placed on the Union market under Article 11(1), and authorities can act against devices already there. See the consequences of having no EU authorised representative.

Cost and appointment

How much does an EU authorised representative cost?

Fees are usually annual and depend on risk class and the number of generic device groups. Our EU authorized representative cost guide compares published figures, and our own rates are on the pricing page.

What does the representative ask for before signing?

The EU declaration of conformity, the technical documentation or access to it, certificates where a notified body is involved, label and IFU drafts, and the manufacturer's EUDAMED actor data. Article 11(3)(a) requires the representative to verify these exist before it acts for you.

Free download. Our five-page checklist lists what an EU authorised representative asks to see before it accepts a mandate, grouped under technical documentation, quality management, the person responsible for regulatory compliance, UDI and EUDAMED registration, labelling and the mandate itself, with the MDR text quoted word for word. Download the EU Authorised Representative Readiness Checklist (PDF).

How do I start?

Send the device list, classes and current certificates through our proposal form. We reply with a written scope and fee.