EU Authorised Representative for Medical Devices: Article 11 Duties, the Mandate and Joint Liability

The mandate gives the representative at least eight tasks, and in defined cases the representative is liable for defective devices jointly and severally with the manufacturer.

The MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) are regulations, directly applicable in every Member State without transposition. The representative rules have applied since 26 May 2021 under the MDR (Article 123(2) as amended by Regulation (EU) 2020/561) and since 26 May 2022 under the IVDR (Article 113(2)), as part of the EU MDR and IVDR framework.

The sections below follow the role from start to finish: when a representative is required, the written mandate and its eight minimum tasks, joint and several liability where the manufacturer is not established in a Member State and has not complied with Article 10, the change of representative, its own person responsible for regulatory compliance (PRRC), its place on the label, documents and registration data, and how to appoint one.

What Is an EU Authorised Representative?

MDR Article 2(32) and IVDR Article 2(25) define the authorised representative as 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 its behalf in relation to specified tasks. The authorised representative is one of the economic operators listed in MDR Article 2(35) and IVDR Article 2(28), with the definition readable in the consolidated MDR text on EUR-Lex.

The representative acts on behalf of the manufacturer in relation to the tasks of the mandate, while the manufacturer keeps the obligations that Article 11(4) bars it from delegating. MDCG 2022-16 (October 2022) is the MDCG guidance on Articles 11 and 12; it is not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99), and notified bodies take it into consideration. How the duties of all roles fit together is set out under economic operators under the MDR and IVDR.

EC REP, EU REP and Other Names for the Role

EC REP and EU REP are the label short forms for the authorised representative, and EU REP is the form of EN ISO 15223-1:2021/A1:2025. EU AR is a further short form used for the same role.

Two short forms name comparable roles under Swiss and United Kingdom rules, and they are listed below.

• CH-REP, the Swiss authorised representative under Articles 51 and 52 of the Swiss Medical Devices Ordinance (MedDO), set out under medical device rules in Switzerland.
• UKRP, the UK Responsible Person, which the Medicines and Healthcare products Regulatory Agency (MHRA) requires for non-UK manufacturers placing devices on the Great Britain market, set out under medical device rules in the United Kingdom.

When the Regulations Require an Authorised Representative

A manufacturer not established in a Member State needs an authorised representative before it places any device on the Union market, because MDR and IVDR Article 11(1) make the designation of a sole authorised representative a condition of placing on the market. The representative then also fixes the reference authority: where the regulations refer to the competent authority of the Member State in which the manufacturer has its registered place of business, Article 11(7) reads that as the competent authority of the Member State of the representative's registered place of business. The MDCG 2022-16 guidance on authorised representatives explains both rules.

The manufacturer also ensures that its representative has the necessary documentation permanently available (MDR Article 10(8) third subparagraph, IVDR Article 10(7)), and its devices reach the Union through an importer. The full market-access set-up is described under non-EU manufacturers under the MDR and IVDR.

One Sole Authorised Representative per Generic Device Group

The mandate is valid only when the authorised representative has accepted it in writing, and it covers at least all devices of the same generic device group (MDR and IVDR Article 11(2)).

MDCG 2022-16 section 4 explains that a manufacturer may work with several authorised representatives only for different generic device groups, and never with two representatives for one group. A single representative for every group is therefore an option, not a legal rule: a manufacturer with three generic device groups may appoint up to three representatives, one per group.

Devices That Need No Authorised Representative

Devices for a clinical investigation or a performance study need no authorised representative; the legal representative of the sponsor takes that place under MDR Article 62(2) and IVDR Article 58(4), as MDCG 2022-16 section 2 explains. The sponsor's legal representative is covered under clinical investigations under the MDR.

The Written Mandate and Its Eight Minimum Tasks

MDR and IVDR Article 11(3) require the mandate to let the authorised representative carry out at least eight tasks, points (a) to (h), from verifying the EU declaration of conformity and technical documentation to terminating the mandate when the manufacturer acts contrary to its obligations. The wording of each point is the same in both regulations, with the IVDR article in the consolidated IVDR text on EUR-Lex. The eight tasks are shown in the table below.

The retention period under task (b) is at least 10 years after the last device, and 15 years for implantable devices, under MDR Article 10(8); under IVDR Article 10(7) it is 10 years. The representative's Member State also matters outside the mandate. Certificates of free sale come from the Member State of the manufacturer's or the representative's registered place of business (MDR Article 60(1), IVDR Article 55(1)), the notice of an anticipated supply interruption goes to the competent authority of the Member State where the manufacturer or its representative is established (MDR and IVDR Article 10a(1)), and classification disputes go to the competent authority of the manufacturer's Member State or, failing that, of the representative's (MDR Article 51(2)).

Duties the Mandate Cannot Transfer

Article 11(4) bars the manufacturer from delegating its core obligations to the authorised representative, and the excluded paragraphs differ between the two regulations. The non-delegable paragraphs of Article 10 are shown in the table below.

The numbers differ because the paragraphs of Article 10 do not line up between the two regulations: the quality management system, for example, sits in MDR Article 10(9) and IVDR Article 10(8). A mandate clause that hands one of the listed paragraphs to the representative is excluded by Article 11(4), so these obligations stay with the manufacturer. What each paragraph requires is set out under manufacturer obligations under MDR and IVDR Article 10.

Terminating the Mandate

An authorised representative that terminates the mandate under Article 11(3)(h) informs the competent authority of its Member State and, where applicable, the notified body immediately (MDR and IVDR Article 11(6)). MDCG 2022-16 section 8 explains that termination is possible only for a whole generic device group. A representative holding a mandate for two generic device groups can therefore end the mandate for one group, but not for part of a group. The handover to a new representative then follows the Article 12 agreement described below.

Joint and Several Liability under Article 11(5)

Under MDR and IVDR Article 11(5), the authorised representative is legally liable for defective devices on the same basis as the manufacturer, and jointly and severally with it, where the manufacturer is not established in a Member State and has not complied with its Article 10 obligations. MDCG 2022-16 section 7 explains the two conditions: the manufacturer's liability for the defective device is established under applicable law, and the manufacturer has not complied with Article 10. "Same basis" means that the representative has the same rights of defence as the manufacturer under the liability regime.

Liability cover starts with the manufacturer. Under MDR Article 10(16) and IVDR Article 10(15), manufacturers have measures in place, proportionate to the risk class, type of device and size of the enterprise, for potential liability under Directive 85/374/EEC. MDCG 2022-16 section 7 names liability insurance as an example of such a measure.

Liability under Directive (EU) 2024/2853 from 9 December 2026

For products placed on the market or put into service after 9 December 2026, Directive (EU) 2024/2853 replaces Directive 85/374/EEC, and its Article 8(1)(c) makes the importer and the authorised representative liable where the manufacturer is established outside the Union. A fulfilment service provider becomes liable only where neither an importer nor an authorised representative is established in the Union. The Directive (EU) 2024/2853 on EUR-Lex, adopted on 23 October 2024 and in force since 8 December 2024, repeals Directive 85/374/EEC with effect from 9 December 2026 (Article 21), and the old directive keeps applying to products placed on the market or put into service before that date. As a directive, it needs national transposition, due by 9 December 2026 (Article 22).

Pending Deletion of Article 11(4) and (5)

The Commission's proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)) would delete paragraphs 4 and 5 of Article 11 in both the MDR and the IVDR, but it is pending: as of 6 November 2026 the European Parliament lists it as "Awaiting committee decision" in its health committee (SANT). The past procedural events recorded in the procedure file on OEIL include the draft report of 30 June 2026.

Until an amending regulation is adopted and published in the Official Journal, both paragraphs apply in full, the non-delegable list as well as the liability rule. Every other change of the proposal is set out under MDR and IVDR amendments.

Changing the Authorised Representative under Article 12

A change of authorised representative needs an agreement between the manufacturer, where practicable the outgoing representative, and the incoming representative that settles at least the four points (a) to (d) of MDR and IVDR Article 12. The four points are shown in the table below.

MDCG 2022-16 section 9 accepts an agreement without the outgoing representative only where a tripartite agreement is not practicable, for example when the outgoing representative is bankrupt or cannot be traced. The incoming representative's own mandate needs the eight Article 11(3) tasks like any other mandate.

The Authorised Representative's Own PRRC

MDR and IVDR Article 15(6) require the authorised representative to have permanently and continuously at its disposal at least one person responsible for regulatory compliance with expertise on the Union regulatory requirements. The MDCG 2019-7 rev.1 guidance on Article 15 (December 2023) states that it must be assumed that this person is located in the Union, which is a guidance position and not an express requirement of Article 15(6). The same guidance adds that the representative's PRRC cannot be the manufacturer's PRRC, even where both entities belong to one large organisation.

Legacy devices follow a narrower rule. MDCG 2022-16 sections 10 and 12 explain that points (c) to (g) of Article 11(3) apply to legacy devices, and that a representative whose mandate covers legacy devices only needs no PRRC. The qualification routes and the full article are explained under PRRC under Article 15.

Where the Authorised Representative Appears: Label, Documents and Registration Data

The authorised representative's name and the address of its registered place of business appear on the label of every device of a manufacturer located outside the Union (MDR Annex I Section 23.2(d), IVDR Annex I Section 20.2(d)). A change of representative therefore also means a label change for new devices.

The EU declaration of conformity names the representative too. Item 1 of MDR and IVDR Annex IV lists the name, registered trade name or trade mark and, if already issued, the single registration number (SRN) of the manufacturer and, where applicable, of its authorised representative, with the address of the registered place of business. Before placing a device on the market, the importer verifies that the manufacturer is identified and that an authorised representative has been designated (MDR and IVDR Article 13(2)).

The representative registers as an actor in EUDAMED before placing on the market, which has been mandatory since 28 May 2026, and receives its SRN from the competent authority (MDR Article 31(1) and (2), IVDR Article 28). The process is explained under EUDAMED actor registration.

The EU REP Marking and Its Coexistence Period

EN ISO 15223-1:2021/A1:2025, with the EU REP marking, has been cited under both regulations since 17 June 2026 (Implementing Decisions (EU) 2026/1231 and 2026/1313). The citation lets manufacturers use the new marking; it does not make EU REP mandatory.

EC REP may still be used until 17 June 2031, and devices labelled with EC REP that are placed on the market before that date may continue to be made available. The switch from EC REP to EU REP needs no notified-body approval, according to the MDCG 2021-5 rev.1 Appendix.

The symbol itself is shown under EU REP symbol and the other label symbols.

How to Appoint an Authorised Representative and Keep the Mandate Compliant

Appoint the authorised representative before the first device of each generic device group is placed on the Union market, and keep the mandate, the documentation and the registration aligned for as long as devices remain on the market. The six steps are listed below in order.

1. Define the generic device groups the mandate covers, with one representative per group (MDR and IVDR Article 11(2)).
2. Write the mandate with all eight Article 11(3) tasks, including the flow of complaints and incident reports for vigilance under the MDR and IVDR.
3. Include the draft mandate in the quality management system documentation for the notified body (MDR Annex IX Section 2.2); for legacy devices, the formal application under MDR Article 120(3c)(e) could be lodged by the manufacturer or its authorised representative by 26 May 2024, as the MDR transition period explains.
4. Give the representative permanent access to the MDR and IVDR technical documentation (MDR Article 10(8) third subparagraph, IVDR Article 10(7)).
5. Confirm the representative's own PRRC under MDR and IVDR Article 15(6).
6. Check that the label, the EU declaration of conformity and the EUDAMED actor data name the same representative (MDR Annex I Section 23.2(d), IVDR Annex I Section 20.2(d), MDR and IVDR Annex IV item 1, MDR Article 31(1), IVDR Article 28).

The Commission's factsheet for authorised representatives, importers and distributors is still online, but its dates are superseded by Regulation (EU) 2023/607.

The Authorised Representative and the Other Economic Operators

The authorised representative is one of four economic operators named by both regulations, and its tasks sit next to, not in place of, those of the importer and the distributor. The MDR adds a fifth role in Article 2(35), the person referred to in MDR Article 22(1) and 22(3), the system or procedure pack producer; the IVDR has no such role. The three neighbouring roles are listed below.

• Importers, which place devices from a third country on the Union market (MDR Article 2(33), IVDR Article 2(26)); MDCG 2021-27 rev.1 accepts the same person as authorised representative and importer for an individual device, as set out under importer obligations under the MDR and IVDR.
• Distributors, which make devices available in the supply chain without being the manufacturer or the importer (MDR Article 2(34), IVDR Article 2(27)), covered under distributor obligations under the MDR and IVDR.
• Distributors, importers or other persons that take on the obligations of a manufacturer under MDR and IVDR Article 16(1), for example by placing a device on the market under their own name, explained under Article 16 MDR.

Authorised Representative Questions

Five questions come up about the authorised representative.

Who can be an EU authorised representative?

Any natural or legal person established in the Union that accepts a written mandate from a manufacturer located outside the Union (MDR Article 2(32), IVDR Article 2(25)), provided it has a person responsible for regulatory compliance permanently and continuously at its disposal (MDR and IVDR Article 15(6)).

Does the notified body see the authorised representative mandate?

Yes: for a manufacturer located outside the Union, the quality management system documentation under MDR Annex IX Section 2.2 includes the draft mandate for the authorised representative. How notified bodies are designated and listed is set out under notified bodies for the MDR and IVDR.

Can the authorised representative also be the importer?

Yes: MDCG 2021-27 rev.1 explains that the same person may act as authorised representative and importer for an individual device, provided it meets the obligations of both roles.

Does the MDR set a fee for an authorised representative?

No: neither the MDR nor the IVDR sets a fee for the mandate, and there is no official figure. A competent authority may charge a fee for actor registration (MDR Article 31(8), IVDR Article 28(8)).

Does a new authorised representative count as a change to the device?

No: MDCG 2020-3 rev.1 section 4.2 lists a change of authorised representative among the changes outside its scope, so it is not a significant change for devices under the MDR Article 120 transitional provision. The other changes that keep or end that status are set out under legacy devices under the MDR.