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Economic Operators under the MDR and IVDR: Manufacturer, Authorised Representative, Importer and Distributor Duties

Economic operators under the MDR and IVDR: the five MDR roles, four IVDR roles, a duties-by-role matrix, EUDAMED registration and the Article 10a notice.

Last updated 12 November 2026 · By the IVDR Guide Editorial Team · How we fact-check · Print this page

Summary

Under the MDR, the economic operators are the manufacturer, the authorised representative, the importer, the distributor and the system or procedure pack producer of MDR Article 22(1) and 22(3) (MDR Article 2(35)); the IVDR has the same four roles without the pack producer (IVDR Article 2(28)).

Their duties sit in Articles 10 to 16 of each regulation and, for the pack producer, in MDR Article 22.

These obligations have applied since 26 May 2021 under the MDR and since 26 May 2022 under the IVDR. The sections below cover the role tests, a duties matrix, the shared duties, distance sales, liability, the IVDR differences and the status as of 6 November 2026.

What Is an Economic Operator under the MDR and IVDR?

An economic operator is a manufacturer, an authorised representative, an importer, a distributor or, under the MDR only, the person who puts together systems or procedure packs under MDR Article 22(1) and 22(3) (MDR Article 2(35); IVDR Article 2(28)). In the German text of the MDR, the term is Wirtschaftsakteur.

The MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) are regulations: both entered into force on 25 May 2017 and are directly applicable in every member state without national transposition. The European Commission's economic operators page lists the same five roles: manufacturers, authorised representatives, importers, distributors and system or procedure pack producers. How the two regulations fit together is set out in EU MDR and IVDR explained.

Five Roles in the MDR, Four in the IVDR

Each role has its own definition in Article 2 of each regulation, and the pack producer has none in the IVDR. The MDR reaches the pack producer only through Article 2(35), which points to the person in Article 22(1) and 22(3).

The five roles, with the definition article in each regulation, are compared in the table below.

Role MDR definition IVDR definition In one line
Manufacturer Article 2(30) Article 2(23) manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its own name or trade mark
Authorised representative Article 2(32) Article 2(25) established in the Union, holds a written mandate from a manufacturer located outside the Union
Importer Article 2(33) Article 2(26) established in the Union, places a device from a third country on the Union market
Distributor Article 2(34) Article 2(27) makes a device available on the market, other than the manufacturer or the importer, up until putting into service
System or procedure pack producer Article 2(35) with Article 22(1) and 22(3) none combines devices or products into a system (Article 2(11)) or a procedure pack (Article 2(10))

How a Company Tells Which Role It Holds

The role follows from what a company does with a device, not from its name: marketing a device under its own name or trade mark makes it the manufacturer, a written mandate from a non-EU manufacturer makes it the authorised representative, placing a device from a third country on the Union market makes it the importer, and making a device available after that makes it a distributor (MDR Article 2(30) to 2(34); IVDR Article 2(23) to 2(27)). Placing on the market is the first making available of a device on the Union market (MDR Article 2(28); IVDR Article 2(21)). MDR and IVDR Article 16(1) give an importer, a distributor or another person the manufacturer's duties when it markets a device under its own name or trade mark, changes its intended purpose or modifies it in a way that affects compliance.

MDCG 2021-27 rev.1 (December 2023), on MDR and IVDR Articles 13 and 14, explains that one person may be both the authorised representative and the importer of a device; MDCG guidance is not legally binding. These terms are explained among the MDR and IVDR definitions.

The Economic Operator Pages in Detail

Nine detailed pages cover each role and each special case this overview summarises: the four roles shared by both regulations, the PRRC, Article 16 cases, non-EU manufacturers, supply interruption and procedure packs. Each row names the question the page answers and the article it rests on.

Page What it answers Legal hook
manufacturer obligations under MDR and IVDR Article 10 the full MDR and IVDR Article 10 list, the quality management system and liability cover; every manufacturer needs a PRRC MDR and IVDR Article 10
EU authorised representative the sole authorised representative per generic device group, the written mandate and joint liability; what "EC REP" on a label refers to MDR and IVDR Articles 11 and 12
importer obligations the MDR and IVDR Article 13 checks before placing, the importer's details and its records MDR and IVDR Article 13
distributor obligations MDR and IVDR Article 14 due care and verification; the CJEU judgment in Case C-10/24 of 4 June 2026 interprets it MDR and IVDR Article 14
person responsible for regulatory compliance who needs a PRRC, the qualifications and the micro and small enterprise rule MDR and IVDR Article 15
MDR and IVDR Article 16 cases when an importer, distributor or other person takes on manufacturer duties; relabelling and repackaging MDR and IVDR Article 16
non-EU manufacturers what a manufacturer outside the Union must set up before selling in the EU MDR and IVDR Articles 11, 13 and 15(6)
supply interruption and discontinuation the 6-month notice, its recipients and the cascade MDR and IVDR Article 10a
systems and procedure packs the Article 22 statement, sterilisation and when a pack becomes a device MDR Article 22

Duties by Operator: The Side-by-Side Matrix

The matrix sets ten duties against the five roles, with the MDR article first and the IVDR article second in each cell. The pack producer column applies under the MDR only.

The "Article 10(8) period" is at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market, and 15 years for implantable devices (MDR Article 10(8), in the consolidated MDR on EUR-Lex).

Duty Manufacturer Authorised representative Importer Distributor Pack producer (MDR only)
Defined in MDR Article 2(30); IVDR Article 2(23) MDR Article 2(32); IVDR Article 2(25) MDR Article 2(33); IVDR Article 2(26) MDR Article 2(34); IVDR Article 2(27) MDR Article 22(1) and 22(3) with MDR Article 2(35)
Main duties article MDR and IVDR Article 10 MDR and IVDR Articles 11 and 12 MDR and IVDR Article 13 MDR and IVDR Article 14 MDR Article 22
EU declaration of conformity and CE marking draws up the declaration and assumes responsibility (MDR Article 19(3); IVDR Article 17(3)) verifies the declaration and the technical documentation (MDR and IVDR Article 11(3)(a)) verifies CE marking and declaration (MDR and IVDR Article 13(2)(a)) verifies CE marking and declaration (MDR and IVDR Article 14(2)(a)) combines CE-marked devices; no additional CE marking (MDR Article 22(1) and 22(5))
medical device labelling label and instructions for use (MDR Annex I Section 23; IVDR Annex I Section 20) its name and address on the label (MDR Annex I Section 23.2(d); IVDR Annex I Section 20.2(d)) its own details on the device, the packaging or an accompanying document (MDR and IVDR Article 13(3)) verifies the importer's details (MDR and IVDR Article 14(2)(c)) name or trade mark, address and Annex I Section 23 information (MDR Article 22(5))
UDI under the MDR and IVDR assigns the UDI; only the manufacturer does (MDCG 2026-5, July 2026) registration and UDI checks (MDR and IVDR Article 11(3)(c)) verifies that a UDI is assigned (MDR and IVDR Article 13(2)(d)) verifies the UDI (MDR and IVDR Article 14(2)(d)) Basic UDI-DI before placing (MDR Article 29(2))
EUDAMED actor registration (mandatory since 28 May 2026) SRN (MDR Article 31(1); IVDR Article 28(1)) SRN (MDR Article 31(1); IVDR Article 28(1)) SRN, plus the two-week check (MDR Article 30(3); IVDR Article 27(3)) not in EUDAMED; national registration possible (MDR Article 30(2); IVDR Article 27(2)) Actor ID (Commission EUDAMED Q&A, Q4)
Records for the Article 10(8) period (MDR; IVDR Article 10(7)) documentation 10 years after the last device, 15 for implantables (MDR Article 10(8)); 10 years (IVDR Article 10(7)) copies of the declaration, technical documentation and certificates (MDR and IVDR Article 11(3)(b)) copies of the declaration and certificates (MDR and IVDR Article 13(9)) identifies suppliers and direct customers (MDR Article 25; IVDR Article 22) pack statement, for the longest period of the combined devices (MDR Article 22(5))
PRRC own PRRC (MDR and IVDR Article 15(1)); micro and small enterprises: permanently and continuously at their disposal (MDR and IVDR Article 15(2)) own PRRC permanently and continuously at its disposal (MDR and IVDR Article 15(6)) where MDR and IVDR Article 16(1) applies (MDCG 2019-7 rev.1) where MDR and IVDR Article 16(1) applies (MDCG 2019-7 rev.1) where MDR Article 22(4) applies (MDCG 2019-7 rev.1)
Supply interruption (MDR and IVDR Article 10a, since 10 January 2025) notifies at least 6 months ahead (MDR and IVDR Article 10a(1)) the competent authority where the manufacturer or authorised representative is established receives the notice (MDR and IVDR Article 10a(1)) passes on a notice received without undue delay (MDR and IVDR Article 10a(3)) passes on a notice received without undue delay (MDR and IVDR Article 10a(3)) passes on a notice received without undue delay (MDR and IVDR Article 10a(3))
Supply-chain identification suppliers and direct customers (MDR Article 25; IVDR Article 22) suppliers and direct customers (MDR Article 25; IVDR Article 22) suppliers and direct customers (MDR Article 25; IVDR Article 22) suppliers and direct customers (MDR Article 25; IVDR Article 22) suppliers and direct customers (MDR Article 25)

Who-and-what level only; each role page holds the full duty list. As of 6 November 2026.

Duties Every Operator Shares

Some duties attach to every economic operator regardless of role: supply-chain identification, passing on supply-interruption notices and, for all roles except the distributor, registration in EUDAMED. The first two run along the same chain, so they share the next section.

Identifying Suppliers and Customers in the Supply Chain

Every economic operator must be able to identify, for the Article 10(8) period, the operator that supplied it and the economic operators, health institutions and healthcare professionals it supplied directly (MDR Article 25; IVDR Article 22).

The same chain carries supply-interruption notices under MDR and IVDR Article 10a, which has applied since 10 January 2025 (inserted by Regulation (EU) 2024/1860). A manufacturer that anticipates an interruption or discontinuation of supply, where it is reasonably foreseeable that this could result in serious harm or risk of serious harm to patients or public health, notifies at least 6 months ahead, other than in exceptional circumstances, the competent authority where it or its authorised representative is established and those it supplies directly (MDR and IVDR Article 10a(1)). An operator receiving the notice passes it to those it supplies directly without undue delay, without changing, adding to or paraphrasing it (MDR and IVDR Article 10a(3)).

Which Operators Must Hold a Registration Number

As of 6 November 2026, manufacturers, authorised representatives and importers must be registered in the EUDAMED actor module before placing a device on the market (custom-made devices aside), and system or procedure pack producers register there too and receive an Actor ID, all mandatory since 28 May 2026. The first three receive a single registration number (SRN) from the competent authority (MDR Article 31; IVDR Article 28). The legal basis is Commission Decision (EU) 2025/2371 together with Regulation (EU) 2024/1860. How the database is organised is explained under EUDAMED under the MDR and IVDR.

Importers also verify, within two weeks of placing a device on the market, that the manufacturer or the authorised representative has entered its data (MDR Article 30(3); IVDR Article 27(3)). Distributors are not registered in EUDAMED; member states may maintain or introduce a national registration of distributors (MDR Article 30(2); IVDR Article 27(2)).

Distance Sales and Online Offers

A device offered online to a person in the Union must comply with the MDR, and so must a device used to provide a diagnostic or therapeutic service at a distance to a person in the Union (MDR Article 6; for IVDs, IVDR Article 6). MDR Article 6 has applied since 26 May 2021 and IVDR Article 6 since 26 May 2022.

The operator offering the device or providing the service makes the EU declaration of conformity available on request, and a member state may require a provider of information society services to cease its activity. MDR Article 6, headed "Distance sales", is one of the general rules of the EU MDR (Regulation (EU) 2017/745).

Liability Across the Supply Chain

The manufacturer must have measures in place for financial cover of its potential liability, proportionate to risk class, type of device and size of enterprise (MDR Article 10(16); IVDR Article 10(15)), and the authorised representative is jointly and severally liable with a non-EU manufacturer that has not complied with Article 10 (MDR and IVDR Article 11(5)). That cover concerns liability under Directive 85/374/EEC.

The Product Liability Directive (EU) 2024/2853 (OJ L, 2024/2853, 18.11.2024) will repeal Directive 85/374/EEC with effect from 9 December 2026 and applies to products placed on the market or put into service after that date. Where the manufacturer is established outside the Union, Directive (EU) 2024/2853 makes the importer and the authorised representative liable (its Article 8(1)(c)).

What Changes under the IVDR

The IVDR keeps the same four roles and the same Article 10 to 16 numbering, but it has no system or procedure pack producer, and its Article 22 is supply-chain identification, not packs. The IVDR's own rules are set out under the IVDR (Regulation (EU) 2017/746).

Two further points differ: registration sits in IVDR Articles 27 and 28 instead of MDR Articles 30 and 31, and documentation is kept for at least 10 years under IVDR Article 10(7), with no 15-year period for implantable devices. Article 10a applies to IVDs in the same way, with the same 6-month notice and cascade.

Economic Operator Rules: Status as of 2026-11-06

As of 6 November 2026, EUDAMED actor registration has been mandatory since 28 May 2026, MDR and IVDR Article 10a has applied since 10 January 2025, and Directive 85/374/EEC will be replaced by Directive (EU) 2024/2853 for products placed on the market or put into service after 9 December 2026. Each change is explained in its section above.

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

A revision is pending: Commission proposal COM(2025) 1023 of 16 December 2025 (2025/0404(COD)), listed as "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026; not law. Past procedural events include the draft report of 30 June 2026 and the amendments of 28 July 2026. It would amend several operator articles; every amending act is listed under MDR and IVDR amendments.

What the Economic Operator Rules Do Not Cover

The economic operator definitions are closed lists: anyone not named in MDR Article 2(35) or IVDR Article 2(28) carries no economic operator duties under that definition. Health institutions, notified bodies and consultants show where the line runs.

Are Health Institutions Economic Operators?

No: a health institution, an organisation whose primary purpose is the care or treatment of patients or the promotion of public health, is defined separately (MDR Article 2(36); IVDR Article 2(29)), and MDR Article 25 and IVDR Article 22 name it as a customer that operators must be able to identify. MDCG 2021-27 rev.1 treats a hospital pharmacy that circulates devices only internally as no distributor, while community pharmacies, shops and retailers are distributors.

Are Notified Bodies or Consultants Economic Operators?

No: notified bodies assess conformity and are not in the economic operator list, and consultants are not defined or regulated by the MDR or the IVDR. What such services do is described under MDR and IVDR consultants.

Sources